Latest news with #Xtandi
Yahoo
11-07-2025
- Business
- Yahoo
Pfizer and Astellas' Xtandi improves OS as combination therapy
Pfizer and Astellas' Xtandi (enzalutamide) has improved overall survival (OS) in patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC), but only as a combination therapy. First approved in 2012, the prostate cancer therapy met the secondary endpoint of OS in the Phase III EMBARK trial (NCT02319837) when combined with leuprolide, compared to placebo plus leuprolide, in patients with nmHSPC with biochemical recurrence (BCR) and high risk for metastasis. Despite this, while a favourable trend was observed, there was no statistical significance between Xtandi monotherapy and placebo or leuprolide. In the trial, patients were randomised across three arms: Xtandi plus leuprolide, placebo plus leuprolide, or Xtandi alone. This update comes two years after the companies announced the trial met its primary endpoint with a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) for patients treated with Xtandi plus leuprolide versus placebo plus leuprolide. Although Pfizer and Astellas have not yet disclosed additional details about the OS data, they stated that full results will be presented at an upcoming medical meeting. They also noted that safety results were consistent with the known safety profile of Xtandi. Carolina Urologic Research Center's medical director Dr Neal Shore said: '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. "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.' Xtandi is currently approved in more than 80 countries, including the US, Europe and Japan. The US Food and Drug Administration (FDA) approved Xtandi for use in nmHSPC with high-risk BCR in November 2023, based on the EMBARK trial meeting its primary endpoint. The European Commission (EC) granted a label expansion for its use in the same patient population in April 2024. GlobalData predicts the prostate cancer market will be worth $22.62bn in 2030. Xtandi sales are set to start dropping due to the drug's patent expiring in 2026 in Europe and 2027 in the US. As a result, GlobalData predicts that sales of Xtandi will reach $5.59bn in 2025 and will drop to $2.24bn in 2030. The pharmaceutical industry is facing one of the most significant patent cliffs of the decade, with major companies preparing for substantial revenue losses, according to market analysts. A recent GlobalData report projects a sharp decline in the proportion of global drug sales protected by patents, with the figure expected to drop to just 4% by 2030. This compares to 12% in 2022 and 6% in 2024. GlobalData is the parent company of Clinical Trials Arena. "Pfizer and Astellas' Xtandi improves OS as combination therapy" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. 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
Yahoo
11-07-2025
- Business
- Yahoo
Pfizer and Astellas' Xtandi improves OS as combination therapy
Pfizer and Astellas' Xtandi (enzalutamide) has improved overall survival (OS) in patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC), but only as a combination therapy. First approved in 2012, the prostate cancer therapy met the secondary endpoint of OS in the Phase III EMBARK trial (NCT02319837) when combined with leuprolide, compared to placebo plus leuprolide, in patients with nmHSPC with biochemical recurrence (BCR) and high risk for metastasis. Despite this, while a favourable trend was observed, there was no statistical significance between Xtandi monotherapy and placebo or leuprolide. In the trial, patients were randomised across three arms: Xtandi plus leuprolide, placebo plus leuprolide, or Xtandi alone. This update comes two years after the companies announced the trial met its primary endpoint with a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) for patients treated with Xtandi plus leuprolide versus placebo plus leuprolide. Although Pfizer and Astellas have not yet disclosed additional details about the OS data, they stated that full results will be presented at an upcoming medical meeting. They also noted that safety results were consistent with the known safety profile of Xtandi. Carolina Urologic Research Center's medical director Dr Neal Shore said: '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. "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.' Xtandi is currently approved in more than 80 countries, including the US, Europe and Japan. The US Food and Drug Administration (FDA) approved Xtandi for use in nmHSPC with high-risk BCR in November 2023, based on the EMBARK trial meeting its primary endpoint. The European Commission (EC) granted a label expansion for its use in the same patient population in April 2024. GlobalData predicts the prostate cancer market will be worth $22.62bn in 2030. Xtandi sales are set to start dropping due to the drug's patent expiring in 2026 in Europe and 2027 in the US. As a result, GlobalData predicts that sales of Xtandi will reach $5.59bn in 2025 and will drop to $2.24bn in 2030. The pharmaceutical industry is facing one of the most significant patent cliffs of the decade, with major companies preparing for substantial revenue losses, according to market analysts. A recent GlobalData report projects a sharp decline in the proportion of global drug sales protected by patents, with the figure expected to drop to just 4% by 2030. This compares to 12% in 2022 and 6% in 2024. GlobalData is the parent company of Clinical Trials Arena. "Pfizer and Astellas' Xtandi improves OS as combination therapy" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
04-07-2025
- Business
- Yahoo
Actinium Highlights ATNM 400 Progress at SNMMI Conference
Actinium Pharmaceuticals, Inc. (NYSE:ATNM) is among the best growth stocks to invest in for the next 5 years. During the Society of Nuclear Medicine & Molecular Imaging annual meeting in New Orleans, Actinium Pharmaceuticals, Inc. (NYSE:ATNM) showcased promising preclinical results for its prostate cancer candidate, ATNM-400. The data indicated that the leading drug demonstrated superior cancer cell killing in contrast to Xtandi (enzalutamide) and greater efficacy than not only Pluvicto (177Lu-PSMA-617) but also Ac-225-PSMA-617 in both laboratory and animal models. As the Actinium's Chairman and CEO, Sandesh Seth, stated, 'ATNM-400 is the ideal cornerstone of our emerging solid tumor pipeline.' A research laboratory arranged with a variety of test tubes filled with liquids for biopharmaceutical research. We have seen how Xtandi, developed by Astellas and Pfizer, secured $5.9 billion in sales in 2024, with Novartis's Pluvicto generating $1.4 billion in the same period. Since ATNM-400 is the potential monotherapy or is complementary to the existing prostate cancer treatments, we have good reason to believe that the drug will be a turnaround point for Actinium Pharmaceuticals, Inc. (NYSE:ATNM). Actinium Pharmaceuticals, Inc. (NYSE:ATNM), based in New York, develops antibody radiation conjugates and other targeted radiotherapies to address the failures of the current oncology therapies. With two clinical-stage product candidates, Actimab-A and Iomab-ACT, the giant aims to build a hospital-focused radiotherapeutics company. While we acknowledge the potential of ATNM 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: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None. Sign in to access your portfolio
Yahoo
20-06-2025
- Business
- Yahoo
Pfizer vs BMY: Which Oncology Drugmaker Is a Better Choice for Now?
Pharma/biotech giants Pfizer PFE and Bristol Myers BMY boast of a dominant position in the lucrative oncology space. Oncology or cancer is one of the most sought-after areas in the pharma/biotech space. As the world at large continues to grapple with a significant increase in the number of cancer patients, the market for cancer medicines is expected to grow. Pfizer is one of the largest and most successful drugmakers in the field of oncology. Oncology sales comprise around 25% of its total revenues. Oncology is a key therapeutic area of focus for Bristol Myers, which is developing and delivering transformational medicines in this space. Both drugmakers have strong footholds in their respective target markets, delivering consistent returns to shareholders. In such a scenario, choosing one stock over another can be challenging. Let us delve into their fundamentals, potential growth prospects, challenges and valuation levels to make a prudent choice. Pfizer has an innovative oncology product portfolio of antibody-drug conjugates (ADCs), small molecules, bispecifics and other immunotherapies that treat a wide range of cancers, including certain types of breast cancer, genitourinary cancer and hematologic malignancies, as well as certain types of melanoma, gastrointestinal, gynecological and lung cancer. Approved drugs in the portfolio include Ibrance, Xtandi, Inlyta, Lorbrena, Bosulif, Braftovi, Mektovi, Orgovyx, Elrexfio and Talzenna. Among these, the breast cancer drug Ibrance is one of the top revenue generators. The acquisition of Seagen in December 2023 strengthened PFE's oncology portfolio by adding four ADCs — Adcetris, Padcev, Tukysa and Tivdak. This initiative boosted oncology sales in 2024 and the first quarter of 2025. Seagen also has some next-generation ADC candidates in its pipeline and their successful development should further strengthen its portfolio. PFE is working on the label expansion of many of its cancer drugs that should boost sales. Pfizer also has oncology biosimilars in its portfolio and markets six of them for cancer. Oncology biosimilars primarily include Retacrit, Ruxience, Zirabev, Trazimera and Nivestym. Pfizer is also advancing a robust pipeline of oncology candidates, with several entering late-stage development. By 2030, it expects to have eight or more blockbuster oncology medicines in its portfolio. Apart from oncology, Pfizer's portfolio has a variety of drugs and vaccines for diseases like COVID-19, inflammation & immunology diseases, rare diseases and migraine, among others. BMY is focused on extending and strengthening its leadership in immuno-oncology (IO), as well as diversifying beyond IO. Leading IO drug Opdivo, approved for several cancer indications, drives its oncology franchise along with Yervoy and Opdualag. The FDA recently granted approval to Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use. Per BMY, this new subcutaneous formulation of Opdivo should help extend the reach and impact of its immuno-oncology franchise to patients into the next decade. Reblozyl, approved for first-line MDS-associated anemia, continues to drive market share within the larger first-line ring sideroblasts negative population. The CAR-T cell therapy Breyanzi is approved to treat the broadest array of B-cell malignancies. BMY has also been active on the acquisition front to expand its oncology portfolio/pipeline. In 2024, BMY acquired Mirati, a commercial-stage targeted oncology company, obtaining the rights to commercialize lung cancer medicine Krazati and to further develop several clinical assets, including PRMT5 Inhibitor. Krazati, a KRAS inhibitor, is approved for second-line non-small cell lung cancer (NSCLC) and is in clinical development with a PD-1 inhibitor for first-line NSCLC. It is also FDA approved for advanced or metastatic KRAS-mutated colorectal cancer with cetuximab. In addition, PRMT5 Inhibitor is a potential first-in-class MTA-cooperative PRMT5 inhibitor, which is advancing to the next stage of development. The acquisition of RayzeBio, a leader in the field of radiopharmaceuticals for solid tumor oncology, provided BMY with RYZ101, a late-stage asset, an investigational new drug engine and in-house manufacturing capabilities. In 2022, BMY acquired Turning Point and added lead asset, repotrectinib, and other clinical and pre-clinical stage assets to its pipeline. Repotrectinib was approved by the FDA in November 2023 and is marketed under the brand name Augtyro. Augtyro, a kinase inhibitor, is indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. It is also intended for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have NTRK gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. Bristol Myers is also focused on developing drugs with presence in hematology, immunology, cardiovascular, neuroscience and other therapeutic areas. The Zacks Consensus Estimate for PFE's 2025 sales implies a year-over-year decrease of 0.6%, and that for earnings per share (EPS) suggests a year-over-year decline of 1.61%. EPS estimates for 2025 and 2026 have moved north in the past 60 days. Image Source: Zacks Investment Research The Zacks Consensus Estimate for BMY's 2025 sales implies a year-over-year decrease of 4.13% while that for EPS suggests an increase of 487.83%. The extraordinary EPS growth rate is attributed to an extremely low EPS figure in 2024 due to acquisition expenses. EPS estimates for both 2025 and 2026 have moved south in the past 60 days. Image Source: Zacks Investment Research From a price-performance perspective, PFE has performed better than BMY so far this year. Shares of PFE have declined 6.8%, while those of BMY have lost 15.4%. The large-cap pharma industry has declined 0.3% in the said period. Image Source: Zacks Investment Research From a valuation standpoint, we use the P/E ratio of the large-cap pharma industry to compare these companies. Going by the same, PFE is slightly more expensive than BMY. PFE's shares currently trade at 7.77X forward earnings, higher than 7.22 for BMY. Image Source: Zacks Investment Research PFE and BMY's attractive dividend yield is a strong positive for investors. However, PFE's dividend yield of 7.2% is higher than BMY's 5.29%. Large pharma/biotech companies are generally considered safe havens for investors interested in this sector. However, with both PFE and BMY stocks currently carrying a Zacks Rank #3 (Hold), choosing one over the other is a complex task. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. PFE has a strong and diverse portfolio but faces challenges like declining sales of its COVID-19 products and U.S. Medicare Part D headwinds in 2025. Several of its key products face patent expirations. Nonetheless, drugs like Vyndaqel, Padcev and Eliquis, and newly acquired products should continue to drive top-line growth. BMY's efforts to revive the top line in the face of generic challenges for key drugs are commendable. However, we believe there is still time before the efforts reap harvest for the company. The outlook for 2025 indicates challenges as of now. Hence, PFE is a better pick at present (despite its slightly pricey valuation), primarily due to the diversity of its portfolio and higher dividend yield compared to BMY. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Bristol Myers Squibb Company (BMY) : Free Stock Analysis Report Pfizer Inc. (PFE) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research 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
Yahoo
23-05-2025
- Business
- Yahoo
Astellas Pharma and Pfizer's Xtandi shows long-term survival in prostate cancer
Astellas Pharma (ALPMY) and Pfizer (PFE) announced longer-term follow-up results from an open-label extension of the Phase 3 ARCHES study, reporting a five-year follow up of overall survival, or OS, benefits and a 30% reduction in the risk of death in men with metastatic hormone-sensitive prostate cancer treated with Xtandi – enzalutamide -, an androgen receptor pathway inhibitor, plus androgen deprivation therapy vs. placebo plus ADT. These data will be presented at the American Society of Clinical Oncology Annual Meeting in Chicago. In patients with high-volume disease a 36-month improvement in median OS was observed. Additional clinically relevant subgroups of patients were evaluated, showing consistently improved survival: low-volume disease; patients who had previously received docetaxel therapy and those who had not received prior docetaxel therapy. The incidence of treatment-emergent adverse events in the five-year follow-up is consistent with prior ARCHES analyses and no new safety signals were identified. These results of the five-year follow-up from the ARCHES study will be submitted for publication in a peer-reviewed journal in the near future. The median OS in the XTANDI group was 8.0 years and 5.8 years in the NSAA group. OS at 96 months was 50% with Xtandi and 40% for NSAA; progression-free survival also favored Xtandi over NSAA. Mean duration of treatment was longer for Xtandi than NSAA, with 33% remaining on Xtandi and 88% of these patients remained at the full dose of 160 mg. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See today's best-performing stocks on TipRanks >> Read More on PFE: Disclaimer & DisclosureReport an Issue Trump Trade: White House announces 'Golden Dome' missile-defense shield Class Action Lawsuit Against Cerevel Therapeutics Holdings, Inc. Pfizer's Strategic Oncology Moves: Balancing Promise and Risk Pfizer's Strategic Focus and Market Challenges Justify Hold Rating Amid Uncertainties HHS says 'taking immediate steps to implement' Trump drug pricing order
