Latest news with #XTANDI
Yahoo
13-07-2025
- Business
- Yahoo
Pfizer (PFE) Reports XTANDI Shows Life-Extending Benefits
Pfizer Inc. (NYSE:PFE) is one of the 13 Best Large Cap Stocks to Buy Right Now. On July 10, Pfizer Inc. (NYSE:PFE) shared positive topline results from the overall survival (OS) analysis from the Phase 3 EMBARK study. This study looked at how XTANDI (enzalutamide), in combination with leuprolide and as a monotherapy, works for men who have a type of prostate cancer called non-metastatic hormone-sensitive prostate cancer (nmHSPC), which is also known as nonmetastatic castration-sensitive prostate cancer or (nmCSPC). The men who were a part of the study had a return of signs of cancer, called biochemical recurrence (BCR), and were at high risk for metastasis. A medical technician wearing protective gloves and a mask mixing a biopharmaceutical solution. For patients who took XTANDI plus leuprolide, the study showed a clear and important improvement in overall survival compared to those who were treated with placebo plus leuprolide. The study showed that using XTANDI can help extend life for men with nmHSPC and high-risk BCR. Currently, XTANDI is approved in over 80 countries, including the US, the European Union, and Japan. Pfizer Inc. (NYSE:PFE) is an American multinational pharmaceutical and biotechnology corporation that is known for discovering, developing, and manufacturing healthcare products, including innovative medicines and vaccines. While we acknowledge the potential of PFE as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 10 Best American Semiconductor Stocks to Buy Now and 11 Best Fintech Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
Yahoo
10-07-2025
- Business
- Yahoo
XTANDI® Plus Leuprolide Significantly Improves Survival Outcomes in Men with Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence
XTANDI: the first and only androgen receptor inhibitor-based regimen to demonstrate overall survival benefit in non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR) NEW YORK & TOKYO, July 10, 2025--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced positive topline results from the overall survival (OS) analysis from the Phase 3 EMBARK study evaluating XTANDI® (enzalutamide), in combination with leuprolide and as a monotherapy, in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as nonmetastatic castration-sensitive prostate cancer or nmCSPC) with biochemical recurrence (BCR) at high risk for metastasis. For patients treated with XTANDI plus leuprolide versus placebo plus leuprolide, EMBARK met the key secondary endpoint with a statistically significant and clinically meaningful improvement in OS. Results also showed a favorable trend towards improved OS for patients treated with XTANDI monotherapy versus placebo plus leuprolide, however the difference did not reach statistical significance. No new safety signals were observed in the analysis, and the safety results were consistent with the demonstrated safety profile of XTANDI.1 "These data demonstrate that treatment with XTANDI can extend life for men with nmHSPC and high-risk BCR who have relapsed after initial curative-intent therapy with prostatectomy, radiation therapy or both, further validating EMBARK's metastasis-free survival (MFS) data," said Neal Shore, M.D., F.A.C.S, START Carolinas/Carolina Urologic Research Center. "While men with nmHSPC with high-risk BCR now have expanded treatment choices, these results demonstrate a clear clinical benefit, including both MFS and OS, supporting the clinical practice of initiating XTANDI for these patients." Among men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy, or both, an estimated 20-40% will experience BCR within 10 years.2 About nine out of 10 men with high-risk BCR will develop metastatic disease, and one in three will die as a result of their metastatic prostate cancer.3 "XTANDI is the only androgen receptor inhibitor-based regimen to demonstrate a survival benefit in metastatic HSPC and nmHSPC with high-risk BCR, as well as castration-resistant prostate cancer, highlighting its significant patient impact in advanced prostate cancer," said Johanna Bendell, M.D., Oncology Chief Development Officer, Pfizer. "These positive results add to the robust clinical support for the use of XTANDI and broaden clinical confidence, offering men with high-risk BCR evidence that they might live longer when they start XTANDI early." In the EMBARK study, patients were randomized to one of three study arms: XTANDI plus leuprolide, placebo plus leuprolide, or XTANDI monotherapy. An initial analysis was previously reported in The New England Journal of Medicine in 2023, demonstrating that the study met its primary endpoint with a statistically significant and clinically meaningful improvement in MFS for patients treated with XTANDI plus leuprolide versus placebo plus leuprolide.4 The most common adverse events (occurring in ≥10% of patients) in the combination group and the leuprolide-alone group were hot flashes and fatigue. The most common adverse events in the monotherapy group were gynecomastia, hot flashes, and fatigue.4 XTANDI is currently approved in more than 80 countries, including in the United States, European Union, and Japan. "Over 1.5 million men with advanced prostate cancer around the world have benefited from treatment with XTANDI since its initial approval in 2012,"5 said Shontelle Dodson, Executive Vice President, Head of Medical Affairs, Astellas. "The scope and rigor of the EMBARK trial exemplify Astellas' and Pfizer's longstanding commitment to the prostate cancer community, and we look forward to sharing detailed findings in a future scientific forum." Detailed OS results from EMBARK will be presented at a future medical meeting. About EMBARK4The Phase 3, randomized, double-blind, placebo-controlled, multi-national trial enrolled 1,068 patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR) at sites in the United States, Canada, Europe, South America, and the Asia-Pacific region. Patients who were considered high-risk BCR had a prostate-specific antigen (PSA) doubling time ≤ 9 months, serum testosterone ≥ 150 ng/dL (5.2 nmol/L), and screening PSA by the central laboratory ≥ 1 ng/mL if they had a radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer or at least 2 ng/mL above the nadir if they had radiotherapy only as primary treatment for prostate cancer. Patients in the EMBARK trial were randomized to receive enzalutamide 160 mg daily plus leuprolide, enzalutamide 160 mg as monotherapy, or placebo plus leuprolide. The primary results from the EMBARK trial were published in The New England Journal of Medicine in 2023. The primary endpoint of the trial was metastasis-free survival (MFS) for enzalutamide plus leuprolide versus placebo plus leuprolide. MFS is defined as the duration of time in months between randomization and the earliest objective evidence of radiographic progression by central imaging or death. For more information on the EMBARK (NCT02319837) trial go to About Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical RecurrenceNon-metastatic hormone- (or castration-) sensitive prostate cancer (nmHSPC or nmCSPC) means there is no detectable evidence of the cancer spreading to distant parts of the body (metastases) with conventional radiological methods (CT/MRI) and the cancer still responds to medical or surgical treatment to lower testosterone levels.6,7 Of men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy, or both, an estimated 20-40% will experience a biochemical recurrence (BCR) within 10 years.8 About 9 out of 10 men with high-risk BCR will develop metastatic disease, and 1 in 3 will die as a result of the recurrence.8 The EMBARK trial focused on men with high-risk BCR. Per the EMBARK protocol, patients with nmHSPC with high-risk BCR are those initially treated by radical prostatectomy or radiotherapy, or both, with a PSA doubling time ≤ 9 months. Patients with nmCSPC who experience BCR after local therapy may be at a higher risk of metastases and death if their PSA doubling time is ≤ 9 months.9 About XTANDI® (enzalutamide)XTANDI (enzalutamide) is an androgen receptor signaling inhibitor. XTANDI is a standard of care and has received regulatory approvals in one or more countries around the world for use in men with metastatic hormone-sensitive prostate cancer (mHSPC), metastatic castration-resistant prostate cancer (mCRPC), non-metastatic castration-resistant prostate cancer (nmCRPC) and non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR). XTANDI is currently approved for one or more of these indications in more than 80 countries, including in the United States, European Union and Japan. Over 1.5 million patients have been treated with XTANDI globally.5 About XTANDI (enzalutamide) and U.S. Important Safety InformationXTANDI (enzalutamide) is indicated for the treatment of patients with: castration-resistant prostate cancer (CRPC) metastatic castration-sensitive prostate cancer (mCSPC) nonmetastatic castration sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR) Important Safety Information Warnings and Precautions Seizure occurred in 0.6% of patients receiving XTANDI in eight randomized clinical trials. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Patients in the study had one or more of the following predisposing factors: use of medications that may lower the seizure threshold, history of traumatic brain or head injury, history of cerebrovascular accident or transient ischemic attack, and Alzheimer's disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment. Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder that can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES. Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in eight randomized clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Permanently discontinue XTANDI for serious hypersensitivity reactions. Ischemic Heart Disease In the combined data of five randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (3.5% vs 2%). Grade 3-4 ischemic events occurred in 1.8% of patients on XTANDI versus 1.1% on placebo. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart disease. Falls and Fractures occurred in patients receiving XTANDI. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. In the combined data of five randomized, placebo-controlled clinical studies, falls occurred in 12% of patients treated with XTANDI compared to 6% of patients treated with placebo. Fractures occurred in 13% of patients treated with XTANDI and in 6% of patients treated with placebo. Embryo-Fetal Toxicity The safety and efficacy of XTANDI have not been established in females. XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI and for 3 months after the last dose of XTANDI. Dysphagia or Choking Severe dysphagia or choking, including events that could be life-threatening requiring medical intervention or fatal, can occur due to XTANDI product size. Advise patients to take each capsule or tablet whole with a sufficient amount of water to ensure that all medication is successfully swallowed. Consider use of a smaller tablet size of XTANDI in patients who have difficulty swallowing. Discontinue XTANDI for patients who cannot swallow capsules or tablets. Adverse Reactions (ARs)In the data from the five randomized placebo-controlled trials, the most common ARs (≥ 10%) that occurred more frequently (≥ 2% over placebo) in XTANDI-treated patients were musculoskeletal pain, fatigue, hot flush, constipation, decreased appetite, diarrhea, hypertension, hemorrhage, fall, fracture, and headache. In the bicalutamide-controlled study, the most common ARs (≥ 10%) reported in XTANDI-treated patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss. In EMBARK, the placebo-controlled study of nonmetastatic CSPC (nmCSPC) with high-risk biochemical recurrence (BCR) patients, Grade 3 or higher adverse reactions during the total duration of treatment were reported in 46% of patients treated with XTANDI plus leuprolide, 50% of patients receiving XTANDI as a single agent, and 43% of patients receiving placebo plus leuprolide. Permanent treatment discontinuation due to adverse reactions during the total duration of treatment as the primary reason was reported in 21% of patients treated with XTANDI plus leuprolide, 18% of patients receiving XTANDI as a single agent, and 10% of patients receiving placebo plus leuprolide. Lab Abnormalities: Lab abnormalities that occurred in ≥ 5% of patients, and more frequently (> 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are hemoglobin decrease, neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, hypophosphatemia, and hypercalcemia. Hypertension: In the combined data from five randomized placebo-controlled clinical trials, hypertension was reported in 14.2% of XTANDI patients and 7.4% of placebo patients. Hypertension led to study discontinuation in < 1% of patients in each arm. Drug Interactions Effect of Other Drugs on XTANDI Avoid coadministration with strong CYP2C8 inhibitors. If coadministration cannot be avoided, reduce the dosage of coadministration with strong CYP3A4 inducers. If coadministration cannot be avoided, increase the dosage of XTANDI. Effect of XTANDI on Other Drugs Avoid coadministration with certain CYP3A4, CYP2C9, and CYP2C19 substrates for which minimal decrease in concentration may lead to therapeutic failure of the substrate. If coadministration cannot be avoided, increase the dosage of these substrates in accordance with their Prescribing Information. In cases where active metabolites are formed, there may be increased exposure to the active metabolites. Please see Full Prescribing Information for additional safety information. About AstellasAstellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands at the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at About Pfizer OncologyAt Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world's most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. About the Pfizer/Astellas CollaborationIn October 2009, Medivation, Inc., which is now part of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize XTANDI (enzalutamide). The companies jointly commercialize XTANDI in the United States, and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States. Astellas Forward-Looking StatementIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development), which is included in this press release is not intended to constitute an advertisement or medical advice. Pfizer Disclosure NoticeThe information contained in this release is as of July 10, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer Oncology, XTANDI (enzalutamide) and an overall survival analysis from the Phase 3 EMBARK study evaluating XTANDI in combination with leuprolide and as a monotherapy, in men with non-metastatic hormone-sensitive prostate cancer with biochemical recurrence at high risk for metastasis, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of XTANDI; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when drug applications for XTANDI may be filed in particular jurisdictions for any potential indications; whether and when regulatory authorities in any jurisdictions may approve any such applications that may be pending or filed for XTANDI, which will depend on a myriad of factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether XTANDI for any potential indication will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety, and/or other matters that could affect the availability or commercial potential of XTANDI; dependence on the efforts and funding by Astellas Pharma Inc. for the development, manufacturing and commercialization of XTANDI; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at and Astellas Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. References 1 Astellas and Pfizer. Data on File, EMBARK results, July 2025. 2 Ward JF, Moul JW. Rising prostate-specific antigen after primary prostate cancer therapy. Nat Clin Pract Urol. 2005 Apr;2(4):174-82. doi: 10.1038/ncpuro0145. PMID: 16474760. 3Antonarakis, Emmanuel S et al. The natural history of metastatic progression in men with prostate-specific antigen recurrence after radical prostatectomy: long-term follow-up. BJU international vol. 109,1 (2012): 32-9. doi:10.1111/j.1464-410X.2011.10422 4Freedland, Stephen J. et al. "Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer." N Engl J Med 2023;389:1453-1465. DOI: 10.1056/NEJMoa2303974 5Astellas. Data on File. XTANDI patient. June 2025. Prostate Cancer: Types of Treatment (12-2022). Accessed June 16, 2025. 7 American Society of Clinical Oncology. ASCO Answers: Prostate Cancer (2023). 8 Ward JF, Moul JW. Rising prostate-specific antigen after primary prostate cancer therapy. Nat Clin Pract Urol. 2005 Apr;2(4):174-82. doi: 10.1038/ncpuro0145. PMID: 16474760. 9 Paller, Channing J et al. "Management of patients with biochemical recurrence after local therapy for prostate cancer." Hematology/oncology clinics of North America vol. 27,6 (2013): 1205-19, viii. doi:10.1016/ Category: Medicines View source version on Contacts Pfizer Media Contact: +1 (212) 733-1225PfizerMediaRelations@ Pfizer Investor Contact: +1 (212) 733-4848IR@ Astellas Contact: +1 (847) Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
10-07-2025
- Business
- Business Wire
XTANDI ® Plus Leuprolide Significantly Improves Survival Outcomes in Men with Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence
NEW YORK & TOKYO--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced positive topline results from the overall survival (OS) analysis from the Phase 3 EMBARK study evaluating XTANDI ® (enzalutamide), in combination with leuprolide and as a monotherapy, in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as nonmetastatic castration-sensitive prostate cancer or nmCSPC) with biochemical recurrence (BCR) at high risk for metastasis. For patients treated with XTANDI plus leuprolide versus placebo plus leuprolide, EMBARK met the key secondary endpoint with a statistically significant and clinically meaningful improvement in OS. Results also showed a favorable trend towards improved OS for patients treated with XTANDI monotherapy versus placebo plus leuprolide, however the difference did not reach statistical significance. No new safety signals were observed in the analysis, and the safety results were consistent with the demonstrated safety profile of XTANDI. 1 'These data demonstrate that treatment with XTANDI can extend life for men with nmHSPC and high-risk BCR who have relapsed after initial curative-intent therapy with prostatectomy, radiation therapy or both, further validating EMBARK's metastasis-free survival (MFS) data,' said Neal Shore, M.D., F.A.C.S, START Carolinas/Carolina Urologic Research Center. 'While men with nmHSPC with high-risk BCR now have expanded treatment choices, these results demonstrate a clear clinical benefit, including both MFS and OS, supporting the clinical practice of initiating XTANDI for these patients.' Among men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy, or both, an estimated 20-40% will experience BCR within 10 years. 2 About nine out of 10 men with high-risk BCR will develop metastatic disease, and one in three will die as a result of their metastatic prostate cancer. 3 'XTANDI is the only androgen receptor inhibitor-based regimen to demonstrate a survival benefit in metastatic HSPC and nmHSPC with high-risk BCR, as well as castration-resistant prostate cancer, highlighting its significant patient impact in advanced prostate cancer,' said Johanna Bendell, M.D., Oncology Chief Development Officer, Pfizer. 'These positive results add to the robust clinical support for the use of XTANDI and broaden clinical confidence, offering men with high-risk BCR evidence that they might live longer when they start XTANDI early.' In the EMBARK study, patients were randomized to one of three study arms: XTANDI plus leuprolide, placebo plus leuprolide, or XTANDI monotherapy. An initial analysis was previously reported in The New England Journal of Medicine in 2023, demonstrating that the study met its primary endpoint with a statistically significant and clinically meaningful improvement in MFS for patients treated with XTANDI plus leuprolide versus placebo plus leuprolide. 4 The most common adverse events (occurring in ≥10% of patients) in the combination group and the leuprolide-alone group were hot flashes and fatigue. The most common adverse events in the monotherapy group were gynecomastia, hot flashes, and fatigue. 4 XTANDI is currently approved in more than 80 countries, including in the United States, European Union, and Japan. 'Over 1.5 million men with advanced prostate cancer around the world have benefited from treatment with XTANDI since its initial approval in 2012,' 5 said Shontelle Dodson, Executive Vice President, Head of Medical Affairs, Astellas. 'The scope and rigor of the EMBARK trial exemplify Astellas' and Pfizer's longstanding commitment to the prostate cancer community, and we look forward to sharing detailed findings in a future scientific forum.' Detailed OS results from EMBARK will be presented at a future medical meeting. About EMBARK 4 The Phase 3, randomized, double-blind, placebo-controlled, multi-national trial enrolled 1,068 patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR) at sites in the United States, Canada, Europe, South America, and the Asia-Pacific region. Patients who were considered high-risk BCR had a prostate-specific antigen (PSA) doubling time ≤ 9 months, serum testosterone ≥ 150 ng/dL (5.2 nmol/L), and screening PSA by the central laboratory ≥ 1 ng/mL if they had a radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer or at least 2 ng/mL above the nadir if they had radiotherapy only as primary treatment for prostate cancer. Patients in the EMBARK trial were randomized to receive enzalutamide 160 mg daily plus leuprolide, enzalutamide 160 mg as monotherapy, or placebo plus leuprolide. The primary results from the EMBARK trial were published in The New England Journal of Medicine in 2023. The primary endpoint of the trial was metastasis-free survival (MFS) for enzalutamide plus leuprolide versus placebo plus leuprolide. MFS is defined as the duration of time in months between randomization and the earliest objective evidence of radiographic progression by central imaging or death. For more information on the EMBARK (NCT02319837) trial go to About Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence Non-metastatic hormone- (or castration-) sensitive prostate cancer (nmHSPC or nmCSPC) means there is no detectable evidence of the cancer spreading to distant parts of the body (metastases) with conventional radiological methods (CT/MRI) and the cancer still responds to medical or surgical treatment to lower testosterone levels. 6,7 Of men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy, or both, an estimated 20-40% will experience a biochemical recurrence (BCR) within 10 years. 8 About 9 out of 10 men with high-risk BCR will develop metastatic disease, and 1 in 3 will die as a result of the recurrence. 8 The EMBARK trial focused on men with high-risk BCR. Per the EMBARK protocol, patients with nmHSPC with high-risk BCR are those initially treated by radical prostatectomy or radiotherapy, or both, with a PSA doubling time ≤ 9 months. Patients with nmCSPC who experience BCR after local therapy may be at a higher risk of metastases and death if their PSA doubling time is ≤ 9 months. 9 About XTANDI ® (enzalutamide) XTANDI (enzalutamide) is an androgen receptor signaling inhibitor. XTANDI is a standard of care and has received regulatory approvals in one or more countries around the world for use in men with metastatic hormone-sensitive prostate cancer (mHSPC), metastatic castration-resistant prostate cancer (mCRPC), non-metastatic castration-resistant prostate cancer (nmCRPC) and non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR). XTANDI is currently approved for one or more of these indications in more than 80 countries, including in the United States, European Union and Japan. Over 1.5 million patients have been treated with XTANDI globally. 5 About XTANDI (enzalutamide) and U.S. Important Safety Information XTANDI (enzalutamide) is indicated for the treatment of patients with: castration-resistant prostate cancer (CRPC) metastatic castration-sensitive prostate cancer (mCSPC) nonmetastatic castration sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR) Important Safety Information Warnings and Precautions Seizure occurred in 0.6% of patients receiving XTANDI in eight randomized clinical trials. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Patients in the study had one or more of the following predisposing factors: use of medications that may lower the seizure threshold, history of traumatic brain or head injury, history of cerebrovascular accident or transient ischemic attack, and Alzheimer's disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment. Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder that can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES. Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in eight randomized clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Permanently discontinue XTANDI for serious hypersensitivity reactions. Ischemic Heart Disease In the combined data of five randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (3.5% vs 2%). Grade 3-4 ischemic events occurred in 1.8% of patients on XTANDI versus 1.1% on placebo. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart disease. Falls and Fractures occurred in patients receiving XTANDI. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. In the combined data of five randomized, placebo-controlled clinical studies, falls occurred in 12% of patients treated with XTANDI compared to 6% of patients treated with placebo. Fractures occurred in 13% of patients treated with XTANDI and in 6% of patients treated with placebo. Embryo-Fetal Toxicity The safety and efficacy of XTANDI have not been established in females. XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI and for 3 months after the last dose of XTANDI. Dysphagia or Choking Severe dysphagia or choking, including events that could be life-threatening requiring medical intervention or fatal, can occur due to XTANDI product size. Advise patients to take each capsule or tablet whole with a sufficient amount of water to ensure that all medication is successfully swallowed. Consider use of a smaller tablet size of XTANDI in patients who have difficulty swallowing. Discontinue XTANDI for patients who cannot swallow capsules or tablets. Adverse Reactions (ARs) In the data from the five randomized placebo-controlled trials, the most common ARs (≥ 10%) that occurred more frequently (≥ 2% over placebo) in XTANDI-treated patients were musculoskeletal pain, fatigue, hot flush, constipation, decreased appetite, diarrhea, hypertension, hemorrhage, fall, fracture, and headache. In the bicalutamide-controlled study, the most common ARs (≥ 10%) reported in XTANDI-treated patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss. In EMBARK, the placebo-controlled study of nonmetastatic CSPC (nmCSPC) with high-risk biochemical recurrence (BCR) patients, Grade 3 or higher adverse reactions during the total duration of treatment were reported in 46% of patients treated with XTANDI plus leuprolide, 50% of patients receiving XTANDI as a single agent, and 43% of patients receiving placebo plus leuprolide. Permanent treatment discontinuation due to adverse reactions during the total duration of treatment as the primary reason was reported in 21% of patients treated with XTANDI plus leuprolide, 18% of patients receiving XTANDI as a single agent, and 10% of patients receiving placebo plus leuprolide. Lab Abnormalities: Lab abnormalities that occurred in ≥ 5% of patients, and more frequently (> 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are hemoglobin decrease, neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, hypophosphatemia, and hypercalcemia. Hypertension: In the combined data from five randomized placebo-controlled clinical trials, hypertension was reported in 14.2% of XTANDI patients and 7.4% of placebo patients. Hypertension led to study discontinuation in < 1% of patients in each arm. Drug Interactions Effect of Other Drugs on XTANDI Avoid coadministration with strong CYP2C8 inhibitors. If coadministration cannot be avoided, reduce the dosage of XTANDI. Avoid coadministration with strong CYP3A4 inducers. If coadministration cannot be avoided, increase the dosage of XTANDI. Effect of XTANDI on Other Drugs Avoid coadministration with certain CYP3A4, CYP2C9, and CYP2C19 substrates for which minimal decrease in concentration may lead to therapeutic failure of the substrate. If coadministration cannot be avoided, increase the dosage of these substrates in accordance with their Prescribing Information. In cases where active metabolites are formed, there may be increased exposure to the active metabolites. Please see Full Prescribing Information for additional safety information. About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+ ® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands at the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at About Pfizer Oncology At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world's most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. About the Pfizer/Astellas Collaboration In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize XTANDI (enzalutamide). The companies jointly commercialize XTANDI in the United States, and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States. Astellas Forward-Looking Statement In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development), which is included in this press release is not intended to constitute an advertisement or medical advice. Pfizer Disclosure Notice The information contained in this release is as of July 10, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer Oncology, XTANDI (enzalutamide) and an overall survival analysis from the Phase 3 EMBARK study evaluating XTANDI in combination with leuprolide and as a monotherapy, in men with non-metastatic hormone-sensitive prostate cancer with biochemical recurrence at high risk for metastasis, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of XTANDI; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when drug applications for XTANDI may be filed in particular jurisdictions for any potential indications; whether and when regulatory authorities in any jurisdictions may approve any such applications that may be pending or filed for XTANDI, which will depend on a myriad of factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether XTANDI for any potential indication will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety, and/or other matters that could affect the availability or commercial potential of XTANDI; dependence on the efforts and funding by Astellas Pharma Inc. for the development, manufacturing and commercialization of XTANDI; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned 'Risk Factors' and 'Forward-Looking Information and Factors That May Affect Future Results', as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at and Astellas Cautionary Notes In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. References 1 Astellas and Pfizer. Data on File, EMBARK results, July 2025. 2 Ward JF, Moul JW. Rising prostate-specific antigen after primary prostate cancer therapy. Nat Clin Pract Urol. 2005 Apr;2(4):174-82. doi: 10.1038/ncpuro0145. PMID: 16474760. 3 Antonarakis, Emmanuel S et al. The natural history of metastatic progression in men with prostate-specific antigen recurrence after radical prostatectomy: long-term follow-up. BJU international vol. 109,1 (2012): 32-9. doi:10.1111/j.1464-410X.2011.10422 4 Freedland, Stephen J. et al. 'Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer.' N Engl J Med 2023;389:1453-1465. DOI: 10.1056/NEJMoa2303974 5 Astellas. Data on File. XTANDI patient. June 2025. 6 Prostate Cancer: Types of Treatment (12-2022). Accessed June 16, 2025. 7 American Society of Clinical Oncology. ASCO Answers: Prostate Cancer (2023). 8 Ward JF, Moul JW. Rising prostate-specific antigen after primary prostate cancer therapy. Nat Clin Pract Urol. 2005 Apr;2(4):174-82. doi: 10.1038/ncpuro0145. PMID: 16474760. 9 Paller, Channing J et al. 'Management of patients with biochemical recurrence after local therapy for prostate cancer.' Hematology/oncology clinics of North America vol. 27,6 (2013): 1205-19, viii. doi:10.1016/ Expand Category: Medicines
Cision Canada
26-06-2025
- Business
- Cision Canada
XTANDI® (enzalutamide) now funded in Ontario for all approved prostate cancer indications Français
XTANDI is the first and only androgen receptor pathway inhibitor (ARPI) indicated and reimbursed in Ontario for use in patients with nmCSPC with biochemical recurrence at high risk for metastasis MARKHAM, ON, June 26, 2025 /CNW/ - Today, Astellas Pharma Canada, Inc. announced that XTANDI ® (enzalutamide) is now funded by the Ontario Drug Benefit Program under the Exceptional Access Program for the treatment of patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence (BCR) at high risk of metastasis (high-risk BCR). i This decision means XTANDI is now publicly reimbursed in Ontario for all of its approved prostate cancer indications. Health Canada granted Astellas market authorization for XTANDI in nmCSPC in January 2024. This approval was expedited as a result of XTANDI's inclusion in Project Orbis, an initiative of regulatory bodies, including Health Canada, with an aim to give patients faster access to promising cancer treatments in some countries around the world. The swift decision to reimburse XTANDI in Ontario is an important milestone towards making this important therapy available to Ontarians. "The public reimbursement of XTANDI in Ontario is important because it expands access to a vital treatment for prostate cancer patients who are at high risk of metastasis," said Tony Finelli, MD, FRCSC, Professor of Surgery and Chair of Urology, University of Toronto, Urologic Oncologist, University Health Network (UHN). "Reducing the barriers to accessing XTANDI allows us as physicians to offer even more comprehensive care to those navigating the challenges of living with prostate cancer." "We applaud Ontario's decision to publicly reimburse XTANDI for the treatment of nmCSPC patients with high-risk BCR," said Sandra Heller, General Manager, Astellas Pharma Canada. "At Astellas, we remain dedicated to ensuring that patients have access to the therapies they require for better health outcomes, and we are honoured to support men facing this difficult journey." Reimbursement Criteria Specific reimbursement criteria must be met for public coverage of XTANDI. Complete information can be found by consulting the Ontario Drug Benefit Program under the Exceptional Access Program for details. About nmCSPC Prostate cancer develops when abnormal cells form and grow in the prostate gland. ii nmCSPC describes the early stage of prostate cancer wherein the disease remains localized and still responds to medical or surgical treatment to lower testosterone levels. iii Of men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy, or both, an estimated 20-40 per cent will experience a biochemical recurrence (BCR) within 10 years. iv About 9 out of 10 men with high-risk BCR will develop metastatic disease, and 1 in 3 will die as a result of their metastatic prostate cancer. v As the most common cancer among Canadian men, prostate cancer accounts for an average of 76 new diagnosis every day. vi It is estimated that about 1 in 8 Canadian men will develop prostate cancer during their lifetime and 1 in 30 will die from it. vii Approximately 98 per cent of cases occur in men above the age of 50. viii About XTANDI (enzalutamide) XTANDI is an androgen receptor (AR) inhibitor that overcomes resistance to conventional antiandrogens by inhibiting AR signaling at multiple steps in the pathway. ix XTANDI is approved for use in men in four prostate cancer disease states across five indications: The treatment of patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk of metastasis (high-risk BCR). The treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). The treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). The treatment of metastatic castration-resistant prostate cancer (mCRPC) in patients: chemotherapy-naïve and post-docetaxel Please consult the Product Monograph for contraindications, warnings, precautions, adverse reactions, interactions, dosing and conditions of clinical use. The product monograph is also available by calling Astellas Medical Information at 1-888-338-1824. XTANDI is a standard of care that has received regulatory approvals in more than 90 countries, including the United States, the European Union and Japan. About XTANDI Patient Assistance Program Astellas is committed to supporting patients prescribed XTANDI through the XTANDI Patient Assistance Program by offering coverage navigation, financial assistance, patient and caregiver education as well as specialty pharmacy dispensing. Patients with a valid prescription can be enrolled by calling 1-855-982-6348. About Astellas Pharma Canada Astellas Pharma Canada, Inc. is a Canadian affiliate of Tokyo-based Astellas Pharma Inc., a global life sciences company conducting business in more than 70 countries around the world. Astellas is committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at SOURCE Astellas Pharma Canada, Inc.
Yahoo
24-05-2025
- Business
- Yahoo
Pfizer Inc. (PFE) Delivers Oncology Milestones with MesoC2 Debut and XTANDI Survival Boost
Pfizer Inc. (NYSE:PFE) has unveiled major advances in cancer research at the 2025 ASCO Annual Meeting, spotlighting robust five-year survival results for XTANDI (enzalutamide) combined with androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer. Data from the Phase 3 ARCHES trial show XTANDI plus ADT cuts the risk of death by 30%, with a 66% five-year survival rate versus 53% for ADT alone. XTANDI is now the first androgen receptor inhibitor to demonstrate such a long-term survival benefit, reinforcing its position as a standard of care for this patient group. Pixabay/Public Domain Despite these clinical milestones and ongoing innovation, including first-in-human studies of new oncology drugs, Pfizer Inc. (NYSE:PFE)'s shares rose just 2%, in line with broader market resilience amid renewed trade tensions. Over the past year, PFE's total return, factoring in dividends, is down 14.32%, lagging the overall US pharmaceuticals sector. Analysts see upside potential, with a consensus price target of $29.50, but note that future performance hinges on continued drug approvals, successful market expansion, and operational efficiency. Pfizer Inc. (NYSE:PFE)'s strategic collaborations and licensing agreements remain key as the company navigates competitive pressures and shifting revenue streams. While we acknowledge the potential of PFE to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than PFE and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
