FDA Alerts

FDA New Drug Approval Roundup (March 2022)

Pluctivo for PSMA-positive mCRPC The US Food and Drug Administration has approved 177Lu-PSMA-617 (Pluctivo; Novartis) for the treatment of patients with metastatic prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC) following other therapies. Approval is based on results from the phase 3 VISION trial that demonstrated patients with treated PSMA-positive...