Merck announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted to support FDA approval of Lynparza® (olaparib) plus abiraterone and prednisone or prednisolone for the first-line treatment of BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC). ODAC voted against approval for the combination beyond this patient population.
Lynparza® is currently approved in the US for patients with homologous recombination repair gene-mutated mCRPC who have progressed following prior treatment with enzalutamide or abiraterone. It is also approved for the treatment of ovarian, breast and pancreatic cancer. The first line combination use is approved in Europe for mCRPC patients in whom chemotherapy is not clinically indicated.Print Page Mail Article