Astellas' PADCEV Gains CDSCO Approval, Doubles Survival

CDSCO approves Astellas' PADCEV (enfortumab vedotin) plus pembrolizumab as first‑line therapy for advanced urothelial cancer in India.
Phase 3 EV‑302 trial showed median overall survival of 31.5 months vs 16.1 months with chemotherapy, HR 0.47 (53% death risk reduction).
Same trial reported median progression‑free survival of 12.5 months versus 6.3 months, HR 0.45 (55% progression risk cut).
Most common ≥ 3% Grade 3+ adverse events were rash, hyperglycemia, neutropenia, neuropathy, diarrhea and anemia; no new safety signals identified.