FDA grants extended approval for Lynparza (olaparib) as a treatment for Ovarian Cancer.- AstraZeneca + Merck Inc.

AstraZeneca and Merck & Co., Inc., (Merck: known as MSD outside the U.S. and Canada) announced that the FDA has granted approval for the PARP inhibitor, Lynparza (olaparib), as follows: .New use of Lynparza as a maintenance treatment for recurrent, epithelial ovarian, fallopian tube or primary peritoneal adult cancer who are in response to platinum-based chemotherapy, regardless of BRCA status; .New use of Lynparza tablets (2 tablets twice daily) as opposed to capsules (8 capsules twice daily); .Lynparza tablets also now indicated (conversion from the current accelerated approval) for the use in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy.