AstraZeneca and MSD’s Lynparza (olaparib) Receives EC’s Approval for BRCA-Mutated Metastatic Pancreatic Cancer

Shots:

• The EC’s approval is based on P-III POLO study assessing Lynparza (300mg, bid) as maintenance monothx. vs PBO in 154 patients in a ratio (3:2) with gBRCAm metastatic pancreatic cancer whose disease had not progressed on 1L platinum-based CT
• The study demonstrated that Lynparza nearly doubled the lifespan of patients without disease progression or death (7.4 vs 3.8 mos.). The safety and tolerability profile of Lynparza in the study was consistent with previous trials
• The approval follows CHMP’s recommendation granted on Jun 01, 2020. Lynparza is a first-in-class PARP inhibitor acts by targeting DDR in cells/tumors harboring a deficiency in HRR (BRCA1& 2 mutation)and is approved in the US & other countries as a 1L maintenance treatment for patients with gBRCAm metastatic pancreatic cancer

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