Mumbai, India, 21st May 2026 – Astellas Pharma India today announced that the Central Drugs Standard Control Organization (CDSCO) has approved PADCEV (enfortumab vedotin [genetical recombination]) in combination with pembrolizumab for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy. This marks the first approved combination therapy in India to demonstrate superiority over platinum-containing chemotherapy, which has been the standard of care for nearly 40 years.
Landmark Clinical Trial Results
The approval is based on data from the global Phase 3 EV-302 trial (also known as KEYNOTE-A39), an open-label, randomized, controlled study evaluating enfortumab vedotin plus pembrolizumab versus platinum-containing chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). The study enrolled 886 patients regardless of PD-L1 status.
The combination therapy nearly doubled median overall survival (OS): 31.5 months (95% CI: 25.4-NR) compared to 16.1 months (95% CI: 13.9-18.3) with chemotherapy, representing a 53% reduction in the risk of death (hazard ratio [HR]=0.47; 95% CI: 0.38-0.58; P<0.00001). Additionally, median progression-free survival (PFS) was significantly extended to 12.5 months (95% CI: 10.4-16.6) versus 6.3 months (95% CI: 6.2-6.5) with chemotherapy, reflecting a 55% reduction in the risk of cancer progression or death (HR=0.45; 95% CI: 0.38-0.54; P<0.00001).
Safety Profile
The safety results from EV-302 are consistent with those previously reported for this combination in the EV-103 trial in cisplatin-ineligible patients. The most common Grade 3 or higher adverse events (≥3%) related to treatment with enfortumab vedotin plus pembrolizumab included maculo-papular rash, hyperglycemia, neutropenia, peripheral sensory neuropathy, diarrhea, and anemia. No new safety signals were identified.
Global Approvals and Ongoing Research
Enfortumab vedotin in combination with pembrolizumab has already been approved in the United States, Europe, Canada, Australia, and several Asian countries. The EV-302 trial is part of a broader clinical program evaluating this combination across multiple stages of urothelial cancer and other solid tumors. Findings were presented at the 2023 European Society for Medical Oncology (ESMO) Congress and published in the New England Journal of Medicine.
About PADCEV
PADCEV is a first-in-class antibody-drug conjugate (ADC) targeting Nectin-4, a protein highly expressed in bladder cancer. Non-clinical data suggest its anticancer activity involves binding to Nectin-4-expressing cells, internalization, and release of monomethyl auristatin E (MMAE), leading to cell cycle arrest and apoptosis. As monotherapy, PADCEV is also indicated for adult patients with la/mUC who have previously received platinum-containing chemotherapy and a PD-1/PD-L1 inhibitor.
Important Safety Information
For important safety information regarding PADCEV, inquiries can be submitted through the Astellas webform at https://www.astellas.com/in/medicines-information-submission.
About Astellas
Astellas is a global life sciences company committed to turning innovative science into value for patients. The company provides transformative therapies in oncology, ophthalmology, urology, immunology, and women's health, and is pioneering new healthcare solutions for diseases with high unmet medical need. More information is available at www.astellas.com.
This press release contains forward-looking statements based on management's assumptions and beliefs. Actual results may differ materially due to risks and uncertainties, including changes in economic conditions, regulatory changes, currency fluctuations, delays in product launches, and intellectual property infringements. This information is not intended as medical advice.
For inquiries: Astellas Pharma India Private Limited, 301, 3rd Floor, C & B Square, 127, Andheri Kurla Road, Andheri (East), Mumbai 400069, India. Customer care: +91-22-61557600. Medical information inquiries: https://www.astellas.com/in/medicines-information-submission. Adverse events reporting: pv@in.astellas.com.
References: 1. Powles T, et al. N Engl J Med. 2024;390:875-888. 2. PADCEV India Approval Letter. 3. Challita-Eid PM, et al. Cancer Res. 2016;76(10):3003-13.
