FDA Panel Votes Against Broad Talazoparib-Enzalutamide Label in Prostate Cancer

An FDA advisory committee on Wednesday unanimously voted against recommending approval of the PARP inhibitor talazoparib (Talzenna) plus enzalutamide (Xtandi) for all patients with metastatic castration-resistant prostate cancer (mCRPC). In an 8-0 vote, members of the Oncologic Drugs Advisory Committee (ODAC) said the available data from the TALAPRO-2 trial do not support a favorable risk-benefit […]