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{"source_url": "https://www.fiercepharma.com", "url": "https://www.fiercepharma.com/pharma/az-merck-s-lynparza-lands-fda-nod-tough-to-treat-pancreatic-cancer?utm_source=internal&utm_medium=rss", "title": "AstraZeneca, Merck's Lynparza lands FDA nod in tough-to-treat pancreatic cancer", "top_image": "https://qtxasset.com/fiercepharma/1577460230/Lynparza.jpg/Lynparza.jpg?srFmebg1wrc.OrbKQojyZ5jHw8R.QyQ_", "meta_img": "https://qtxasset.com/fiercepharma/1577460230/Lynparza.jpg/Lynparza.jpg?srFmebg1wrc.OrbKQojyZ5jHw8R.QyQ_", "images": ["https://qtxasset.com/styles/content_well_thumb/s3/fiercepharma/1577727574/GettyImages948197202Tiny.jpg/GettyImages948197202Tiny.jpg?4FtXzK6L4.IG5yXRDnz0wCJgczIjPnBw&itok=g0yVA3Dc", "https://qtxasset.com/styles/content_well_thumb/s3/fiercepharma/1577391922/AdvertisingAgencyCloudImage.jpg/AdvertisingAgencyCloudImage.jpg?10E6v9BT9lVA_zUi_ypH5IjBFzX.ngw7&itok=-oOPH9z8", "https://qtxasset.com/styles/breakpoint_sm_default_480px_w/s3/fiercepharma/1577460230/Lynparza.jpg/Lynparza.jpg?5602geQkcrmvidu6TYG5fsMnm9Fy23dr&itok=4AiNjprj", "https://qtxasset.com/field/image/Carly.jpg?DQwVLu57l4ptXdNWFR9RqF5cZnfmRUFr", "https://www.fiercepharma.com/themes/custom/tektite/assets/images/footer-questex.svg", "https://www.fiercepharma.com/themes/custom/tektite/assets/images/logo-questex.svg", "https://qtxasset.com/fiercepharma/1577460230/Lynparza.jpg/Lynparza.jpg?srFmebg1wrc.OrbKQojyZ5jHw8R.QyQ_", "https://qtxasset.com/styles/content_well_thumb/s3/fiercepharma/1577377728/UCB__800x.png?W6CyUwQLtcG8FXykHkSW.cG1rc6u5gRr&itok=lJyddqRv", "https://www.fiercepharma.com/themes/custom/tektite_fierce/assets/images/logo/logo-pharma.svg"], "movies": [], "text": "Earlier this month, FDA experts voted\u2014barely\u2014that the agency should approve AstraZeneca and Merck\u2019s Lynparza in pancreatic cancer. But that small majority was enough to convince regulators to follow suit.\n\nThe FDA greenlighted the drug Friday as a maintenance treatment for patients with germline BRCA-mutated disease who've already received a round of platinum-based chemo. The approval followed a priority review designation, awarded over the summer, and an orphan drug designation.\n\nWith the approval, AZ and Merck add a third disease area to the drug\u2019s resume, which already includes indications in ovarian and breast cancers. And, for the third time, Lynparza is the first of its class of PARP inhibitors\u2014which includes entrants from GlaxoSmithKline and Clovis Oncology\u2014to break into a cancer type.\n\nWhitepaper Simplify and Accelerate Drug R&D With the MarkLogic Data Hub Service for Pharma R&D Researchers are often unable to access the information they need. And, even when data does get consolidated, researchers find it difficult to sift through it all and make sense of it in order to confidently draw the right conclusions and share the right results. Discover how to quickly and easily find, synthesize, and share information\u2014accelerating and improving R&D. Learn More\n\nRELATED: AZ, Merck's Lynparza fends off pancreatic cancer, cutting progression risk in half\n\nRegulators based the go-ahead on data from the phase 3 Polo trial, presented at this year\u2019s American Society of Clinical Oncology meeting, which demonstrated Lynparza could slash the risk of disease worsening or death by 47%.\n\nThe results are \u201cvery exciting\u201d considering \u201cwe are now able to offer a chemo-free option in maintenance to patients who for over a decade haven\u2019t had any meaningful improvement,\u201d Dave Fredrickson, executive vice president and global head of AstraZeneca\u2019s oncology business unit, said at the time.\n\nBut FDA staffers weren\u2019t so sure. They brought Lynparza\u2019s case before an expert advisory committee, citing concerns about the Polo study\u2019s size and the limitations of imaging technology to accurately measure tumor size.\n\nUltimately, those experts voted 7-5 in favor of approval, though, with the lack of other treatment options giving the drug a boost. While pancreatic cancer is rare, it\u2019s also particularly deadly, bearing the lowest survival rate of the most common cancers. It\u2019s also the only major cancer with a single-digit five-year survival rate in nearly every country, according to AstraZeneca.\n\nRELATED: AZ, Merck's Lynparza narrowly snags FDA panel backing in pancreatic cancer\n\nWhile the vote was a narrow one, the corresponding approval didn\u2019t surprise SVB Leerink analyst Andrew Berens and his colleagues, who, following the committee meeting, called an FDA nod \u201cmore likely than not.\u201d And while they model a small sales boost from the latest OK\u2014just $155 million in the U.S. and $50 million in the EU\u2014they also \u201cbelieve this favorable AdCom and potential approval could create a 'halo effect' for Lynparza, perhaps making the drug the PARP inhibitor of choice for the majority of medical oncologists,\" they wrote at the time.", "keywords": [], "meta_keywords": ["AstraZeneca", "Merck & Co.", "Lynparza", "pancreatic cancer", "drug approval", "PARP inhibitors", "Oncology drugs"], "tags": ["PARP inhibitors", "Oncology drugs", "drug approval", "pancreatic cancer"], "authors": ["Carly Helfand"], "publish_date": null, "summary": "", "article_html": "", "meta_description": "Earlier this month, FDA experts voted\u2014barely\u2014that the agency should approve AstraZeneca and Merck\u2019s Lynparza in pancreatic cancer. But that small majority was enough to persuade regulators to follow suit. The agency green-lighted the PARP inhibitor Friday for certain patients with BRCA-mutated disease who've already undergone chemotherapy.", "meta_lang": "en", "meta_favicon": "/themes/custom/tektite_fierce/favicon.ico", "meta_data": {"og": {"site_name": "FiercePharma", "url": "https://www.fiercepharma.com/pharma/az-merck-s-lynparza-lands-fda-nod-tough-to-treat-pancreatic-cancer", "title": "AstraZeneca, Merck's Lynparza lands FDA nod in tough-to-treat pancreatic cancer", "description": "Earlier this month, FDA experts voted\u2014barely\u2014that the agency should approve AstraZeneca and Merck\u2019s Lynparza in pancreatic cancer. But that small majority was enough to persuade regulators to follow suit. The agency green-lighted the PARP inhibitor Friday for certain patients with BRCA-mutated disease who've already undergone chemotherapy.", "image": {"identifier": "https://qtxasset.com/fiercepharma/1577460230/Lynparza.jpg/Lynparza.jpg?srFmebg1wrc.OrbKQojyZ5jHw8R.QyQ_", "secure_url": "https://qtxasset.com/fiercepharma/1577460230/Lynparza.jpg/Lynparza.jpg?srFmebg1wrc.OrbKQojyZ5jHw8R.QyQ_"}}, "twitter": {"card": "summary_large_image", "description": "Earlier this month, FDA experts voted\u2014barely\u2014that the agency should approve AstraZeneca and Merck\u2019s Lynparza in pancreatic cancer. But that small majority was enough to persuade regulators to follow suit. The agency green-lighted the PARP inhibitor Friday for certain patients with BRCA-mutated disease who've already undergone chemotherapy.", "title": "AstraZeneca, Merck's Lynparza lands FDA nod in tough-to-treat pancreatic cancer", "url": "https://www.fiercepharma.com/pharma/az-merck-s-lynparza-lands-fda-nod-tough-to-treat-pancreatic-cancer", "image": "https://qtxasset.com/fiercepharma/1577460230/Lynparza.jpg/Lynparza.jpg?srFmebg1wrc.OrbKQojyZ5jHw8R.QyQ_"}, "news_keywords": "AstraZeneca, Merck & Co., Lynparza,pancreatic cancer, drug approval, PARP inhibitors, Oncology drugs", "description": "Earlier this month, FDA experts voted\u2014barely\u2014that the agency should approve AstraZeneca and Merck\u2019s Lynparza in pancreatic cancer. But that small majority was enough to persuade regulators to follow suit. The agency green-lighted the PARP inhibitor Friday for certain patients with BRCA-mutated disease who've already undergone chemotherapy.", "keywords": "AstraZeneca, Merck & Co., Lynparza,pancreatic cancer, drug approval, PARP inhibitors, Oncology drugs", "article": {"tag": "Oncology drugs"}, "gtm-keywords": "AstraZeneca, Merck & Co., Lynparza", "gtm-article": 452941, "parsely-tags": "Oncology drugs", "gtm-topics": "pancreatic cancer, drug approval, PARP inhibitors, Oncology drugs", "parsely-section": "Pharma", "parsely-title": "AstraZeneca, Merck's Lynparza lands FDA nod in tough-to-treat pancreatic cancer", "gtm-contenttype": "Article", "gtm-section": "Pharma", "parsely-post-id": 452941, "parsely-author": "Carly Helfand", "parsely-image-url": "https://qtxasset.com/fiercepharma/1577460230/Lynparza.jpg/Lynparza.jpg?srFmebg1wrc.OrbKQojyZ5jHw8R.QyQ_", "parsely-type": "post", "parsely-pub-date": "2019-12-30T06:55:00-0500", "parsely-link": "https://www.fiercepharma.com/pharma/az-merck-s-lynparza-lands-fda-nod-tough-to-treat-pancreatic-cancer", "Generator": "Drupal 8 (https://www.drupal.org)", "MobileOptimized": "width", "HandheldFriendly": "true", "viewport": "width=device-width, initial-scale=1.0", "msapplication-TileColor": "#da532c", "msapplication-TileImage": "/themes/custom/tektite_fierce/mstile-144x144.png?v=wAAmkK2yLl", "theme-color": "#ffffff"}, "canonical_link": "https://www.fiercepharma.com/pharma/az-merck-s-lynparza-lands-fda-nod-tough-to-treat-pancreatic-cancer"} |
