lutetium Lu 177 vipivotide tetraxetan (Pluvicto): FDA status

Approved Approved Apr 16, 2025. Indication: PSMA positive metastatic castration resistant prostate cancer prior to chemotherapy. Company: Novartis.

Regulatory history

• Apr 16, 2025: Approved. 177Lu radioligand therapy approval called practice changing in mCRPC. CancerNetwork
• Mar 28, 2025: Label expanded. FDA expanded Pluvicto label to PSMA positive mCRPC patients regardless of prior chemotherapy. Cure Today

All products in the FDA Tracker