CDSCO approves Astellas' PADCEV for First-Line Advanced Bladder Cancer Treatment

VMPL

Mumbai (Maharashtra) [India], May 21: Astellas Pharma India today announced that PADCEV™ (enfortumab vedotin) in combination with pembrolizumab is now approved for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy in India. This is the first approved combination therapy in India to offer an alternative to platinum-containing chemotherapy, the current standard of care for first-line treatment of advanced urothelial cancer.

The approval by Central Drugs Standard Control Organization was supported by results from the Phase 3 EV-302 clinical trial which explored the efficacy and safety of enfortumab vedotin in combination with pembrolizumab in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). [1] The treatment combination resulted in a median overall survival of 31.5 months (95% CI: 25.4-NR) compared to 16.1 months (95% CI: 13.9-18.3) with platinum-containing chemotherapy, with a hazard ratio of 0.47 indicating a 53% reduction in risk of death (95% Confidence Interval [CI]: 0.38-0.58; P