NEW YORK – AstraZeneca and Merck said on Tuesday that the US Food and Drug Administration has accepted a supplemental new drug application for their PARP inhibitor olaparib (Lynparza) as adjuvant treatment for BRCA1/2-mutated early-stage breast cancer that is also HER2-negative and at high risk of relapse.
The FDA also granted the application priority review, which means the agency may issue a decision in the first quarter of 2022.
AstraZeneca and Merck — who share rights to develop and commercialize olaparib — are seeking approval for the drug as a treatment for patients who have undergone surgical resection for their cancer and who have received chemotherapy either before or after surgery.
The application includes data from the Phase III OlympiA clinical trial, in which adjuvant olaparib delayed cancer progression in germline BRCA1/2-mutated, early-stage, HER2-negative breast cancer patients versus placebo. The PARP inhibitor reduced the risk of invasive breast cancer recurrence, secondary cancers, or death by 42 percent compared to placebo.
The OlympiA results, presented in June during the American Society of Clinical Oncology virtual annual meeting, enrolled patients with high-risk disease, defined according to clinical features such as node positivity and by the presence of germline BRCA1/2 mutations. The trial results sparked debate as to whether all breast cancer patients should be assessed for these mutations associated with increased cancer risk.