CDSCO approves Astellas’ PADCEV for first-line advanced Bladder cancer treatment

CAR-T Digest - August 2020

21 May 2026: CDSCO approves Astellas’ PADCEV for first-line advanced Bladder cancer treatment

Astellas Pharma’s PADCEV has been approved by CDSCO for first-line treatment of locally advanced or metastatic urothelial cancer, expanding frontline treatment options for eligible patients in India
The approval is based on results from the global Phase 3 EV-302/KEYNOTE-A39 trial, which evaluated PADCEV in combination with pembrolizumab versus standard platinum-based chemotherapy in previously untreated patients
In the EV-302 study, the PADCEV plus pembrolizumab combination demonstrated a significant survival benefit, reducing the risk of death by nearly 53% compared with chemotherapy, while also substantially improving progression-free survival
PADCEV is an antibody-drug conjugate (ADC) targeting Nectin-4, a protein highly expressed in urothelial cancer cells, allowing targeted delivery of its cytotoxic payload directly to tumors while working synergistically with pembrolizumab immunotherapy
With this approval, India joins a growing number of countries adopting PADCEV-based regimens as a new standard of care for frontline advanced urothelial cancer, reflecting the increasing role of ADCs in transforming treatment paradigms across solid tumors