AstraZeneca and Merck announced that the U.S. Food and Drug Administration (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
“Physicians have almost three years of clinical experience with LYNPARZA on the market and we are now pleased to bring this important medicine, in a new tablet formulation, to a broader group of women,” Sean Bohen, executive vice president, global medicines development and chief medical officer of AstraZeneca, said. “Today’s approvals validate more than 10 years of dedicated research behind LYNPARZA, the world’s first PARP inhibitor, which now provides oncologists with the greater flexibility for use in terms of treatment settings. It builds on our recently-announced collaboration with Merck, which aims to further increase the number of treatment options available to patients.”