The FDA has accepted and granted priority review for a supplemental New Drug Application (sNDA) for the use of olaparib tablets in patients with germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic settings.
This is the first submission for a PARP inhibitor outside ovarian cancer and the third indication submission for olaparib 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.
Olaparib was first approved in December 2014 as a capsule formulation, making it the first ever PARP inhibitor to be approved. Olaparib tablets are currently being tested in a range of tumor types, including breast, prostate, and pancreatic cancers.
Olaparib 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.