Astellas Pharma’s Bladder Cancer Drug Wins Full FDA Approval

July 14, 2021

Astellas Pharma’s Padcev has gained full approval from the FDA as a treatment for adults with locally advanced or metastatic bladder cancer.

The FDA previously granted Padcev (enfortumab vedotin-ejfv) an accelerated approval in 2019 for urothelial cancer patients who received either a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy before or after surgery.

The full approval includes an updated indication for patients who are ineligible for chemotherapy containing cisplatin and those who have received at least one prior line of therapy.

View today's stories