AstraZeneca and Merck & Co Receive the US FDA Advisory Committee’s Recommendation on Approval of Lynparza (olaparib) as 1L Maintenance Treatment for Germline BRCA-Mutated Metastatic Pancreatic Cancer

 AstraZeneca and Merck & Co Receive the US FDA Advisory Committee’s Recommendation on Approval of Lynparza (olaparib) as 1L Maintenance Treatment for Germline BRCA-Mutated Metastatic Pancreatic Cancer

AstraZeneca and Merck Receive the US FDA Advisory Committee’s Recommendation on Approval of Lynparza (olaparib) as 1L Maintenance Treatment for Germline BRCA-Mutated Metastatic Pancreatic Cancer

Shots:

  • The US FDA’s ODAC voted 7 to 5 in favor of recommending Lynparza as 1L maintenance monotherapy for patients with gBRCAm metastatic adenocarcinoma of the pancreas that has not progressed on 1L platinum-based CT
  • The ODAC recommendation is based on P-III POLO study assessing Lynparza vs PBO in 154 patients in a ratio (3:2) with gBRCAm metastatic pancreatic cancer. Results: OS (18.9 vs 18.1 mos.); improvement in PFS and reduction in risk of disease progression by 47%; time at which patients lived without disease progression (7.4 vs 3.8mos.); safety & tolerability profile is consistent with the previous studies
  • Lynparza (olaparib) is a first-in-class PARP inhibitor acts by targeting DNA damage response (DDR) in cells/tumors harboring a deficiency in HRR (BRCA1& 2 mutation). In Aug’2019, the US FDA has accepted sNDA of Lynparza for above indication and granted PR with its expected PDUFA date in Q4’19

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Medical Marketing & Media

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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