The poly(ADP-ribose) polymerase inhibitor Lynparza (olaparib) has become the first FDA-approved medicine targeting BRCA mutations in early breast cancer.
The drug was developed by AstraZeneca (NSDQ:AZN) and Merck & Co. (NYSE:MRK), which is known as MSD outside of the U.S.
Lynparza is already approved for a number of other indications. FDA approved the drug to treat advanced ovarian cancer in 2014. Indications followed for maintenance treatment of ovarian cancer and for germline BRCA-mutated metastatic breast cancer, pancreatic and advanced ovarian cancer. In 2020, FDA granted additional indications related to ovarian cancer and prostate cancer.
The most recent indication of Lynparza covers the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer.
The indication is limited to patients who have received prior chemotherapy before or after surgery.
In weighing the decision, FDA reviewed results from the OlympiA Phase3 study, which was also summarized in The New England Journal of Medicine.
Approximately 91% of U.S. breast cancer patients are diagnosed at an early stage.
BRCA mutations are present in 5-10% of patients.
Phase 3 trials are underway for olaparib in colorectal, endometrial, lung and squamous cell cancers.