- Central Drugs Standard Control Organization approval was based on the global Phase 3 EV-302 trial (also known as KEYNOTE-A39) where the combination treatment nearly doubled median overall survival and significantly extended progression free survival outcomes¹ -

Mumbai, India, 21^st May 2026 : Astellas Pharma India today announced that PADCEV^TM (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<0.00001).¹ Furthermore, the treatment combination resulted in a median progression-free survival of 12.5 months (95% CI: 10.4-16.6) compared to 6.3 months (95% CI: 6.2-6.5) with chemotherapy, with a hazard ratio of 0.45 indicating a 55% reduction in the risk of cancer progression or death (95% CI: (0.38-0.54); P<0.00001).¹

The safety results in EV-302 are consistent with those previously reported for this combination in EV-103 in cisplatin-ineligible patients with la/mUC. The most common (≥3%) Grade 3 or higher adverse events (AEs) related to treatment with enfortumab vedotin in combination with pembrolizumab were maculo-papular rash, hyperglycemia, neutropenia, peripheral sensory neuropathy, diarrhea, and anemia. No new safety signals were identified.¹

Enfortumab vedotin in combination with pembrolizumab has also been approved in the US, Europe, Canada, Australia and a number of countries in Asia.

About EV-302

The EV-302 trial is an open-label, randomized, controlled Phase 3 study, evaluating enfortumab vedotin in combination with pembrolizumab versus platinum-containing chemotherapy in patients with previously untreated la/mUC. The study enrolled 886 patients with previously untreated la/mUC who were eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status. Patients were randomized to receive either enfortumab vedotin in combination with pembrolizumab or platinum-containing chemotherapy. The dual primary endpoints of this trial are OS and PFS per RECIST v1.1 by blinded independent central review (BICR). Select secondary endpoints include ORR per RECIST v1.1 by BICR, DOR per RECIST v1.1 by BICR, and safety.¹

The EV-302 trial is part of an extensive clinical program evaluating this combination in multiple stages of urothelial cancer and other solid tumors. Findings from EV-302 were presented at the 2023 European Society for Medical Oncology (ESMO) Congress and published in the New England Journal of Medicine.¹

About PADCEV^TM (enfortumab vedotin [genetical recombination])

PADCEV (enfortumab vedotin [genetical recombination]) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.^, Non-clinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4-expressing cells, followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).¹⁰

PADCEV is indicated 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.

PADCEV as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor 1 or programmed death ligand 1 inhibitor.

Important Safety Information

For important Safety Information for PADCEV, submit your inquiry through our webform - 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. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.

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In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.

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Contacts for inquiries or additional information:

Astellas Pharma India Private Limited
301, 3rd Floor, C & B Square, 127, Andheri Kurla Road, Andheri (East), Mumbai 400069 India, Customer care no. +91-22-61557600

If you have a medical information inquiry regarding Astellas medicines, submit your inquiry through our webform - https://www.astellas.com/in/medicines-information-submission

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1.Powles T, et al. Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer. N Engl J Med. 2024;390:875-888.

2. PADCEV India Approval Letter.

3. Challita-Eid PM, et al. Enfortumab vedotin antibody-drug conjugate targeting nectin-4 is a highly potent therapeutic agent in multiple preclinical cancer models. Cancer Res. 2016;76(10):3003-13.