India Approves PADCEV-Pembrolizumab Combo for Advanced Bladder Cancer Treatment

India has approved a breakthrough treatment combination for advanced bladder cancer, marking what oncologists describe as one of the biggest shifts in urothelial cancer care in decades.

Astellas Pharma announced that the Central Drugs Standard Control Organization (CDSCO) has approved PADCEV (enfortumab vedotin) in combination with Pembrolizumab for the first-line treatment of adults with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy.

The approval is significant because platinum-based chemotherapy has remained the frontline standard of care for advanced urothelial cancer for nearly 40 years. The newly approved regimen is the first therapy in India shown to outperform conventional platinum chemotherapy in this patient category.

The CDSCO decision was based on findings from the global Phase 3 EV-302 trial , also known as KEYNOTE-A39 , which evaluated the efficacy and safety of the combination in patients with previously untreated locally advanced or metastatic urothelial cancer.

The study enrolled 886 patients worldwide and produced what experts have called “practice-changing” results. Patients treated with the PADCEV-pembrolizumab combination recorded a median overall survival of 31.5 months , compared with 16.1 months for those receiving platinum chemotherapy. The treatment reduced the risk of death by 53% .

The combination also significantly improved progression-free survival, extending it to 12.5 months versus 6.3 months under chemotherapy, while reducing the risk of disease progression or death by 55% .

Urothelial cancer, the most common form of bladder cancer, is frequently diagnosed at advanced stages in India because symptoms such as blood in urine are often ignored. Specialists say survival outcomes for metastatic disease have historically remained poor, making the EV-302 findings particularly important.

PADCEV is a first-in-class antibody-drug conjugate targeting the Nectin-4 protein , which is highly expressed in bladder cancer cells. Once attached, it delivers a potent anti-cancer agent directly into tumor cells, disrupting cell division and triggering programmed cell death. Pembrolizumab, an immunotherapy drug, helps the immune system recognize and attack cancer cells more effectively.

The therapy is already being used in several major healthcare markets, including the United States, European Union member countries, Canada, Australia, Japan and multiple Asian nations , reflecting growing global acceptance of the regimen as a new standard for advanced urothelial cancer treatment.

The safety profile observed in the EV-302 trial remained consistent with earlier studies. Common severe side effects included rash, hyperglycemia, neutropenia, neuropathy, diarrhea and anemia, though researchers reported no new safety concerns.

Researchers are now studying the combination in earlier stages of bladder cancer as well, including before surgery and as post-surgical therapy aimed at preventing recurrence, signalling a potentially broader future role for the regimen in oncology care.