Merck provides update on FDA panel vote on LYNPARZA plus abi/pred

Merck announced that the U.S. FDA’s Oncologic Drugs Advisory Committee, by a vote of 11 to 1 with one abstention, supported FDA approval of LYNPARZA plus abiraterone and prednisone or prednisolone for the first-line treatment of adult patients with BRCA-mutated metastatic castration-resistant prostate cancer. The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients, recommending against approval beyond this patient population.