AstraZeneca and Merck, known as MSD outside the U.S. and Canada, announced that the FDA has accepted and granted priority review for a supplemental New Drug Application (sNDA) for the use of Lynparza (olaparib) tablets in patients with germline BRCA-mutated (gBRCA), HER2-negative metastatic breast cancer (MBC) who have been previously treated with chemotherapy either in the neoadjuvant, adjuvant or metastatic settings. A Prescription Drug User Fee Act (PDUFA) date is set for the first quarter of 2018.
This is the first submission for a poly ADP-ribose polymerase (PARP) inhibitor outside ovarian cancer and the third indication submission for Lynparza in the U.S. The sNDA is based on the positive results from the phase III OlympiAD trial published in the New England Journal of Medicine.
Lynparza was first approved under the FDA’s Accelerated Approval program in December 2014, as a capsule formulation, making it the first PARP inhibitor ever approved. Since then, more than 3,000 advanced ovarian cancer patients have been treated with Lynparza. Lynparza tablets are currently being tested in a range of tumor types, including breast, prostate and pancreatic cancers.
Lynparza tablets are currently approved in the U.S. as a maintenance treatment for adult patients with recurrent, epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, regardless of BRCA status. The medicine is also indicated for use in adult patients with deleterious or suspected deleterious gBRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy; patients for this indication are selected for therapy based on an FDA-approved companion diagnostic.