FDA OKs Olaparib-Abiraterone for Metastatic Prostate Cancer
The FDA has approved the PARP inhibitor olaparib (Lynparza) in combination with abiraterone (Zytiga) for BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC), the agency announced Wednesday. Adult patients should be selected for the combination therapy — which is given with prednisone (or prednisolone) — based on an FDA-approved companion diagnostic test to detect deleterious or suspected […]
Drugmaker Pulls Third-Line PARP Inhibitor Approval in Ovarian Cancer
Clovis Oncology has voluntarily withdrawn the indication for rucaparib (Rubraca) as a third-line treatment in BRCA-mutated ovarian cancer after an overall survival (OS) analysis showed a signal for potential harm, according to a filing with the Securities and Exchange Commission (SEC). “Based on further discussions with the FDA following submission of ARIEL4 OS data previously […]