Latest news with #Tagrisso
Economic Times
4 days ago
- Business
- Economic Times
AstraZeneca breast cancer medicine slows disease by over six months
Agencies Camizestrant works as a hormone therapy to stop estrogen from attaching to cancer cells and helping them to grow. New York: AstraZeneca Plc's experimental breast cancer pill delayed disease progression by over six months, according to data from a new study that is likely to capture investors' attention. Camizestrant, in combination with other cancer medicines, helped patients with a specific type of breast cancer to live for a median of 16 months without their cancer progressing, compared with 9.2 months for those taking the current standard treatment. Astra hopes the study data, presented at the American Society of Clinical Oncology's annual meeting in Chicago, will help establish a new treatment strategy for some breast cancer patients. Camizestrant works as a hormone therapy to stop estrogen from attaching to cancer cells and helping them to grow. When other potential uses for camizestrant are taken into account, Astra believes the drug could bring in over $5 billion in annual sales. But analysts are more cautious as other similar drugs have failed, with Barclays estimating potential peak year sales at $3.6 billion. AstraZeneca has established itself as a cancer drug powerhouse under CEO Pascal Soriot, with medicines including Tagrisso and Imfinzi fueling growth.
Time of India
4 days ago
- Business
- Time of India
AstraZeneca breast cancer medicine slows disease by over six months
AstraZeneca's new breast cancer pill, Camizestrant, shows promising results. The drug delayed cancer progression by over six months in trials. Camizestrant, combined with other medicines, helped patients live longer without cancer worsening. AstraZeneca hopes this data will establish a new treatment approach. The company anticipates significant sales, though analysts offer more conservative estimates. Tired of too many ads? Remove Ads New York: AstraZeneca Plc's experimental breast cancer pill delayed disease progression by over six months, according to data from a new study that is likely to capture investors' attention. Camizestrant , in combination with other cancer medicines, helped patients with a specific type of breast cancer to live for a median of 16 months without their cancer progressing, compared with 9.2 months for those taking the current standard hopes the study data, presented at the American Society of Clinical Oncology's annual meeting in Chicago, will help establish a new treatment strategy for some breast cancer works as a hormone therapy to stop estrogen from attaching to cancer cells and helping them to other potential uses for camizestrant are taken into account, Astra believes the drug could bring in over $5 billion in annual sales. But analysts are more cautious as other similar drugs have failed, with Barclays estimating potential peak year sales at $3.6 billion. AstraZeneca has established itself as a cancer drug powerhouse under CEO Pascal Soriot, with medicines including Tagrisso and Imfinzi fueling growth.
Yahoo
21-05-2025
- Business
- Yahoo
AstraZeneca Stock Declines 6% in 3 Months: Time to Buy the Dip?
AstraZeneca AZN stock has declined 6.4% in the past three months. Although AstraZeneca faces its share of challenges, a significant portion of this price decline is attributed to broader market uncertainties and a volatile macroeconomic environment. The sky-high tariffs imposed by the United States and retaliatory tariffs by China and some other countries hurt global stock markets. Though the massive tariffs imposed by the United States and China are now on a pause, it is only a temporary suspension, and no one knows what will happen after the 90-day tariff suspension ends. The uncertainty around tariffs and trade production measures remains, slowing down economic growth. Although pharmaceuticals have been exempted from tariffs in the first round, they could be Trump's target in the next round, considering the President's goal to shift pharmaceutical production back to the United States, primarily from European and Asian countries. Trump and the Republican government also continue to stress on the control of drug prices with the latest attempt being his 'most favored nations' policy.' Let's understand AZN's strengths and weaknesses to better analyze how to play the stock in an uncertain macro environment. AstraZeneca boasts a diversified geographical footprint as well as a product portfolio with several blockbuster medicines. AstraZeneca now has 16 blockbuster medicines in its portfolio with sales exceeding $1 billion, including Tagrisso, Fasenra, Farxiga, Imfinzi, Lynparza (partnered with Merck [MRK]), Calquence and Ultomiris. These drugs are driving the company's top line, backed by increasing demand trends. The company is confident that the growth will continue in 2025. Almost every new product it has launched in recent years has done well. Newer drugs like Wainua, Airsupra, Saphnelo, Datroway (partnered with Daiichi Sankyo) and Truqap are also expected to continue to contribute to top-line growth in 2025. Oncology is AstraZeneca's biggest segment. The company is working on strengthening its oncology product portfolio through label expansions of existing products and progressing oncology pipeline candidates. Oncology sales (comprising around 41% of AstraZeneca's total revenues) rose 13% in the first quarter of 2025, generating $5.6 billion in sales. The strong oncology performance is being driven by medicines such as Tagrisso, Merck-partnered Lynparza, Imfinzi, Calquence and Daiichi Sankyo-partnered Enhertu. A key new cancer drug approval was that of Truqap for HR-positive, HER2-negative (HR+ HER2-) breast cancer. The drug has seen a robust launch, recording sales of $430 million in 2024 and $132 million in the first quarter of 2025. In January this year, AstraZeneca and partner Daiichi's drug, Datroway, was approved by the FDA for HR+ HER2- breast cancer, while a regulatory application is under review for EGFR-mutated non-small cell lung cancer (NSCLC). Datroway witnessed encouraging early launch signals in the United States. AstraZeneca expects continued growth of its oncology medicines in 2025, particularly Tagrisso, Enhertu and Imfinzi, despite the incremental impact of the Part D redesign. The impact of Part D redesign hurt sales of AZN's older drugs, Tagrisso, Lynparza and Ultomiris, as well as newer drugs, Truqap and Wainua, in the United States in the first quarter of 2025, with the trend expected to continue through the rest of the year. AstraZeneca expects Farxiga and Lynparza to be included in the volume-based procurement plans in China in mid-2025, which can hurt sales of these drugs in the country. Pricing and competitive pressure in Europe and generic competition in some emerging markets are expected to hurt sales of some drugs. Brilinta generics are expected to be launched in the United States in 2025. This will hurt sales of the drug. Biosimilar versions of Soliris were launched in the United States in March 2025, which, along with successful conversion to Ultomiris, biosimilar pressure in Europe and unfavorable order timing in certain tender markets, is expected to lead to a continuous decline in sales of Soliris. AstraZeneca is facing ongoing investigations at its China subsidiary. The Chinese authorities are investigating some current and former AstraZeneca employees at its China subsidiary for medical insurance fraud, illegal drug importation and personal information breaches. AZN stock has risen 8.2% so far this year againsta decrease of 3.1% for the industry. The stock has also outperformed the sector and S&P 500 index, as seen in the chart below. Image Source: Zacks Investment Research From a valuation standpoint, AstraZeneca is slightly expensive. Going by the price/earnings ratio, the company's shares currently trade at 14.93 forward earnings, slightly higher than 14.74 for the industry. However, AZN's stock is trading below its 5-year mean of 18.05. The stock is also much cheaper than other large drugmakers like Eli Lilly LLY and Novo Nordisk NVO. Eli Lilly and Novo Nordisk currently dominate the obesity space. Image Source: Zacks Investment Research The Zacks Consensus Estimate for 2025 earnings has risen from $4.47 per share to $4.50 per share over the past 60 days. For 2026, earnings estimates have risen from $4.95 per share to $4.98 per share over the same timeframe. Image Source: Zacks Investment Research Despite the potential impact from Part D redesign, AstraZeneca expects total revenues to grow by a high single-digit percentage at CER in 2025. Growth momentum in Oncology and CVRM(cardiovascular, renal and metabolism) segments is expected to continue in 2025. However, in Rare Disease, though AstraZeneca expects growth in 2025, it will be at a slower pace than in 2024. Regarding the potential impact of tariffs, AstraZeneca had a positive tone on the first-quarter conference call. The company said it has limited commercialized finished medicines imported to the United States from China, which lowers its exposure to potential China tariffs on pharmaceuticals. It also has a substantial and growing manufacturing footprint in the United States, and the majority of its medicines sold in the United States are manufactured domestically. It does import some medicines from Europe but believes that if tariffs on pharmaceutical imports from Europe are implemented in a similar range as other industries, it will be manageable and allow the company to remain within its guidance range for EPS. In 2025, AstraZeneca expects core EPS to increase by a low double-digit percentage. Backed by its new products and pipeline drugs, AstraZeneca believes it can post industry-leading top-line growth in the 2025-2030 period. AstraZeneca expects to generate$80 billion in total revenues by 2030, a significant increase from the $54 billion it generated in 2024. By the said time frame, AstraZeneca plans to launch 20 new medicines, with nine new medicines already launched/approved. It believes that many of these new medicines will have the potential to generate more than $5 billion in peak-year revenues. The company is also on track to achieve a mid-30s percentage core operating margin by 2026 Considering AZN's growth prospects, investors may take advantage of the recent dip and consider buying this Zacks Rank #2 (Buy) stock, more so as it is trading below its five-year mean. Consistently rising estimates also indicate analysts' optimistic outlook for growth. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. 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 AstraZeneca PLC (AZN) : Free Stock Analysis Report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Merck & Co., Inc. (MRK) : Free Stock Analysis Report Eli Lilly and Company (LLY) : 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
21-05-2025
- Health
- Yahoo
Tagrisso® approved (with conditions) in Canada for patients with unresectable, Stage III EGFR-mutated non-small cell lung cancer (NSCLC)
Based on LAURA Phase III trial results which showed patients who took TAGRISSO after CRT had a median progression-free survival of more than 3 years MISSISSAUGA, ON, May 21, 2025 /CNW/ - Health Canada has granted a Notice of Compliance with conditions (NOC/c) for Tagrisso® (osimertinib) for the treatment of patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations) and whose disease has not progressed during or following platinum based chemoradiation therapy. A validated test is required to identify EGFR mutation-positive status prior to treatment.1 The conditional approval was based on results from the LAURA Phase III trial, which were presented during the Plenary Session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine.2 Tagrisso reduced the risk of disease progression or death by 84% compared to placebo (hazard ratio 0.16; 95% confidence interval 0.10-0.24; p<0.001) as assessed by blinded independent central review. Median progression-free survival (PFS) was 39.1 months in patients treated with Tagrisso versus 5.6 months for placebo.2 Overall survival (OS) results remain immature at this current analysis. The trial continues to assess OS as a secondary endpoint.2 Each year in Canada, 32,000 people are diagnosed with lung cancer3, and 80-85% of these patients are diagnosed with NSCLC, the most common form of lung cancer.4 Approximately 15% of NSCLC patients in Canada have EGFR mutations.5 Nearly one in five people diagnosed with NSCLC has an unresectable tumour.6 "With this approval, we're now able to offer people living with Stage III, EGFR-mutated NSCLC an oral targeted therapy," says Dr. Paul Wheatley-Price, Associate Professor of Medicine at the University of Ottawa and Medical Oncologist at the Ottawa Hospital, and host of the Lung Cancer Voices podcast. "The LAURA trial demonstrated that with Tagrisso, patients were able to live, on average, for more than three years without disease progression, which is an impressive result in this patient population." "With the approval of Tagrisso, we have a new approach for managing unresectable Stage III non-small cell lung cancer with EGFR mutations," says Dr. Nathalie Daaboul, hemato-oncologist at the Centre intégré de cancérologie de la Montérégie, University of Sherbrooke. "The LAURA trial results reinforce the potential benefits of Tagrisso after CRT, offering hope for extended progression free survival and improved outcomes, which is good news for patients." The safety profile of Tagrisso in this disease setting was manageable and was consistent with Tagrisso monotherapy and the known safety profile of treatment following platinum-based chemoradiation therapy. The discontinuation rate for Tagrisso due to AEs was 8.4%. The most common adverse reactions of any grade (>10%) were radiation pneumonitis (48.3%), diarrhea (35.7%), rash (35.7%), paronychia (23.1%), dry skin (17.5%), stomatitis (15.4%) and pruritus (12.6%). The most common adverse drug reactions grade 3 and above (>1%) were diarrhea (2.1%), radiation pneumonitis (2.1%) and ILD (1.4%).2 "We're pleased to see that Health Canada has recognized the efficacy of Tagrisso demonstrated in the LAURA study," says Shem Singh, Executive Director, Lung Cancer Canada. "The ability for people with lung cancer to have more time living life without their cancer progressing is so important for their quality of life and that of their family, and this new treatment option will be welcome news for those with stage III EGFR-mutated NSCLC." About Lung CancerLung cancer remains the most diagnosed cancer in Canada (excluding non-melanoma skin cancers) and is the leading cause of death from cancer in this country.7 In Canada, roughly two-thirds (70%) of lung cancer cases are diagnosed in stages III or IV where the disease has already spread locally or metastasized, resulting in poorer survival outcomes and the treatment goal is no longer curative.8 As such, the 5-year survival rate for lung cancer is only 22% - significantly lower than prostate (91%), breast (89%) and colorectal (67%) cancers.7 About LAURA2LAURA is a randomized, double-blind, placebo-controlled, multi-centre, global Phase III trial in patients with unresectable, Stage III EGFRm NSCLC whose disease has not progressed following definitive platinum-based CRT. Patients were treated with Tagrisso 80mg once-daily oral tablets until disease progression, unacceptable toxicity or other discontinuation criteria were met. Upon progression, patients in the placebo arm were offered treatment with Tagrisso. The trial enrolled 216 patients in more than 145 centres across more than 15 countries, including the US, Europe, South America and Asia. This is the analysis of the primary endpoint of PFS. The trial is ongoing and will continue to assess the secondary endpoint of OS. About TagrissoTagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. Tagrisso (40mg and 80mg once-daily oral tablets) has been used to treat approximately 1,000,000 patients since launch worldwide. About AstraZeneca AstraZeneca is a global, science-led biopharmaceutical business whose innovative medicines are used by millions of patients worldwide. The company's core areas of scientific focus are Oncology; Cardiovascular, Renal and Metabolic (CVRM); Rare Disease; Respiratory & Immunology; and Vaccine & Immune Therapies. In Canada, the company employs more than 2,400 people and recently announced a major expansion of its research footprint in Mississauga – including the expansion of its AstraZeneca R&D Hub and the creation of a new Alexion Development Hub for Rare Diseases. AstraZeneca was recently recognized as one of Canada's Top 100 Employers, one of Canada's Most Admired Corporate Cultures, and a Greater Toronto Top Employer. AstraZeneca is committed to contributing to a more sustainable future for people, society and planet taking important steps to help tackle some of the most pressing sustainability challenges globally – from climate and biodiversity loss, to health equity and health system resilience. AstraZeneca was one of the first seven companies globally to have its net zero targets verified by the Science-Based Targets initiative (SBTi) Corporate Net-Zero Standard. For more information, please visit the company's website at Tagrisso® is a registered trademark of AstraZeneca AB, used under license by AstraZeneca Canada Inc. References________________________________ 1 Tagrisso (osimertinib), Product Monograph, AstraZeneca Canada Inc., April 23, 2025.2 Lu S., et al. Osimertinib After Chemoradiotherapy in Stage III EGFR-Mutated NSCLC. The New England Journal of Medicine. 2024; 391(7): 585-297.3 Lung Cancer Canada. Facts About Lung Cancer. Available at: Accessed on March 11, 2025.4 Lung Cancer Canada. Your Comprehensive Guide to Lung Cancer – Types of Lung Cancer. Available at: chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/ documents/ Accessed on March 11, 2025.5 O'Sullivan DE, et al. Prevalence, Treatment Patterns, and Outcomes of Individuals with EGFR Positive Metastatic Non-Small Cell Lung Cancer in a Canadian Real-World Setting: A Comparison of Exon 19 Deletion, L858R, and Exon 20 Insertion EGFR Mutation Carriers. Current Oncology. 2022; 29: 7198-7208.6 Seung SJ, et al. Restrospective Cohort Study of Unresectable Stage III Non-Small Cell Lung Cancer in Canada. Current Oncology. 2020 Aug; 27(4) e354-e360.7 Lung Cancer Canada. Hard Facts Poster, 2023. Available at: Accessed on June 12, 2024.8 Canadian Partnership Against Cancer. Lung Cancer and Equity Report – Diagnosis and Treatment. Available at: Accessed on June 12, 2024. SOURCE AstraZeneca Canada Inc. View original content to download multimedia: 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
Cision Canada
21-05-2025
- Health
- Cision Canada
Tagrisso® approved (with conditions) in Canada for patients with unresectable, Stage III EGFR-mutated non-small cell lung cancer (NSCLC) Français
Based on LAURA Phase III trial results which showed patients who took TAGRISSO after CRT had a median progression-free survival of more than 3 years MISSISSAUGA, ON, May 21, 2025 /CNW/ - Health Canada has granted a Notice of Compliance with conditions (NOC/c) for Tagrisso ® (osimertinib) for the treatment of patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations) and whose disease has not progressed during or following platinum based chemoradiation therapy. A validated test is required to identify EGFR mutation-positive status prior to treatment. 1 The conditional approval was based on results from the LAURA Phase III trial, which were presented during the Plenary Session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine. 2 Tagrisso reduced the risk of disease progression or death by 84% compared to placebo (hazard ratio 0.16; 95% confidence interval 0.10-0.24; p<0.001) as assessed by blinded independent central review. Median progression-free survival (PFS) was 39.1 months in patients treated with Tagrisso versus 5.6 months for placebo. 2 Overall survival (OS) results remain immature at this current analysis. The trial continues to assess OS as a secondary endpoint. 2 Each year in Canada, 32,000 people are diagnosed with lung cancer 3, and 80-85% of these patients are diagnosed with NSCLC, the most common form of lung cancer. 4 Approximately 15% of NSCLC patients in Canada have EGFR mutations. 5 Nearly one in five people diagnosed with NSCLC has an unresectable tumour. 6 "With this approval, we're now able to offer people living with Stage III, EGFR -mutated NSCLC an oral targeted therapy," says Dr. Paul Wheatley-Price, Associate Professor of Medicine at the University of Ottawa and Medical Oncologist at the Ottawa Hospital, and host of the Lung Cancer Voices podcast. "The LAURA trial demonstrated that with Tagrisso, patients were able to live, on average, for more than three years without disease progression, which is an impressive result in this patient population." "With the approval of Tagrisso, we have a new approach for managing unresectable Stage III non-small cell lung cancer with EGFR mutations," says Dr. Nathalie Daaboul, hemato-oncologist at the Centre intégré de cancérologie de la Montérégie, University of Sherbrooke. "The LAURA trial results reinforce the potential benefits of Tagrisso after CRT, offering hope for extended progression free survival and improved outcomes, which is good news for patients." The safety profile of Tagrisso in this disease setting was manageable and was consistent with Tagrisso monotherapy and the known safety profile of treatment following platinum-based chemoradiation therapy. The discontinuation rate for Tagrisso due to AEs was 8.4%. The most common adverse reactions of any grade (>10%) were radiation pneumonitis (48.3%), diarrhea (35.7%), rash (35.7%), paronychia (23.1%), dry skin (17.5%), stomatitis (15.4%) and pruritus (12.6%). The most common adverse drug reactions grade 3 and above (>1%) were diarrhea (2.1%), radiation pneumonitis (2.1%) and ILD (1.4%). 2 "We're pleased to see that Health Canada has recognized the efficacy of Tagrisso demonstrated in the LAURA study," says Shem Singh, Executive Director, Lung Cancer Canada. "The ability for people with lung cancer to have more time living life without their cancer progressing is so important for their quality of life and that of their family, and this new treatment option will be welcome news for those with stage III EGFR -mutated NSCLC." About Lung Cancer Lung cancer remains the most diagnosed cancer in Canada (excluding non-melanoma skin cancers) and is the leading cause of death from cancer in this country. 7 In Canada, roughly two-thirds (70%) of lung cancer cases are diagnosed in stages III or IV where the disease has already spread locally or metastasized, resulting in poorer survival outcomes and the treatment goal is no longer curative. 8 As such, the 5-year survival rate for lung cancer is only 22% - significantly lower than prostate (91%), breast (89%) and colorectal (67%) cancers. 7 About LAURA 2 LAURA is a randomized, double-blind, placebo-controlled, multi-centre, global Phase III trial in patients with unresectable, Stage III EGFR m NSCLC whose disease has not progressed following definitive platinum-based CRT. Patients were treated with Tagrisso 80mg once-daily oral tablets until disease progression, unacceptable toxicity or other discontinuation criteria were met. Upon progression, patients in the placebo arm were offered treatment with Tagrisso. The trial enrolled 216 patients in more than 145 centres across more than 15 countries, including the US, Europe, South America and Asia. This is the analysis of the primary endpoint of PFS. The trial is ongoing and will continue to assess the secondary endpoint of OS. About Tagrisso Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. Tagrisso (40mg and 80mg once-daily oral tablets) has been used to treat approximately 1,000,000 patients since launch worldwide. About AstraZeneca AstraZeneca is a global, science-led biopharmaceutical business whose innovative medicines are used by millions of patients worldwide. The company's core areas of scientific focus are Oncology; Cardiovascular, Renal and Metabolic (CVRM); Rare Disease; Respiratory & Immunology; and Vaccine & Immune Therapies. In Canada, the company employs more than 2,400 people and recently announced a major expansion of its research footprint in Mississauga – including the expansion of its AstraZeneca R&D Hub and the creation of a new Alexion Development Hub for Rare Diseases. AstraZeneca was recently recognized as one of Canada's Top 100 Employers, one of Canada's Most Admired Corporate Cultures, and a Greater Toronto Top Employer. AstraZeneca is committed to contributing to a more sustainable future for people, society and planet taking important steps to help tackle some of the most pressing sustainability challenges globally – from climate and biodiversity loss, to health equity and health system resilience. AstraZeneca was one of the first seven companies globally to have its net zero targets verified by the Science-Based Targets initiative (SBTi) Corporate Net-Zero Standard. For more information, please visit the company's website at Tagrisso ® is a registered trademark of AstraZeneca AB, used under license by AstraZeneca Canada Inc. 1 Tagrisso (osimertinib), Product Monograph, AstraZeneca Canada Inc., April 23, 2025. 2 Lu S., et al. Osimertinib After Chemoradiotherapy in Stage III EGFR-Mutated NSCLC. The New England Journal of Medicine. 2024; 391(7): 585-297. 3 Lung Cancer Canada. Facts About Lung Cancer. Available at: Accessed on March 11, 2025. 4 Lung Cancer Canada. Your Comprehensive Guide to Lung Cancer – Types of Lung Cancer. Available at: chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/ documents/ Accessed on March 11, 2025. 5 O'Sullivan DE, et al. Prevalence, Treatment Patterns, and Outcomes of Individuals with EGFR Positive Metastatic Non-Small Cell Lung Cancer in a Canadian Real-World Setting: A Comparison of Exon 19 Deletion, L858R, and Exon 20 Insertion EGFR Mutation Carriers. Current Oncology. 2022; 29: 7198-7208. 6 Seung SJ, et al. Restrospective Cohort Study of Unresectable Stage III Non-Small Cell Lung Cancer in Canada. Current Oncology. 2020 Aug; 27(4) e354-e360. 7 Lung Cancer Canada. Hard Facts Poster, 2023. Available at: Accessed on June 12, 2024. 8 Canadian Partnership Against Cancer. Lung Cancer and Equity Report – Diagnosis and Treatment. Available at: Accessed on June 12, 2024.
