AstraZeneca and Merck & Co’s Lynparza Receive the US FDA’s Approval as a 1L Maintenance Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer

AstraZeneca and MSD’s Report Results of Lynparza in P-III PROfound Study for Metastatic Castration-Resistant Prostate Cancer with Homologous Recombination Repair Gene Mutation

Shots:

  • The approval follows the US FDA Oncologic drugs Advisory Committee (ODAC) on 17 Dec based on P-III POLO trial, which involves assessing of Lynparza tablets (300 mg bid) as maintenance monothx vs. PBO in 154 patients in ratio (3:2) with gBRCAm metastatic pancreatic cancer whose disease had not progressed on at least 16 weeks on 1L Pt-based chemotherapy
  • The study resulted in improvement in median progression-free survival (7.4 mos. vs 3.8 mos.), 47% reduced risk of disease progression or death, respond ratio (23% vs 12%), median duration of treatment in excess of 2 yrs. (24.9 mos. vs 3.7 mos.), OS (18.9 mos. vs 18.1 mos.), safe and tolerable
  • AstraZeneca and Merck & Co’s (MSD outside the United States and Canada) Lynparza (olaparib) is a first-in-class PARP inhibitor targeted to block DNA damage response (DDR) in cells/tumors harboring a deficiency in homologous recombination repair (HRR) and is approved in 65 countries

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