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

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