On September 18, 2026 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of PADCEV (enfortumab vedotin), in combination with Keytruda (pembrolizumab), as neoadjuvant treatment (before surgery) and then continued after radical cystectomy (surgery) as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer (MIBC) in the European Union (EU).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The CHMP based its positive opinion on results from the Phase 3 EV-304 clinical trial (KEYNOTE-B15), in which perioperative (neoadjuvant and adjuvant) enfortumab vedotin plus pembrolizumab significantly improved Event-Free Survival (EFS) and Overall Survival (OS) compared to standard-of-care neoadjuvant gemcitabine and cisplatin chemotherapy in adults with MIBC who were cisplatin-eligible.
Moitreyee Chatterjee-Kishore, Ph.D., MBA, Executive Vice President and Head of Oncology Development, Astellas
"Nearly half of patients with MIBC see their cancer return within five years, even after receiving neoadjuvant gemcitabine and cisplatin chemotherapy. This positive CHMP opinion brings us closer to changing that for patients across Europe, based on the significant survival improvements seen with perioperative enfortumab vedotin plus pembrolizumab."
In the trial, perioperative enfortumab vedotin plus pembrolizumab reduced the risk of tumor recurrence, progression, or death by 47% (Hazard Ratio (HR) 0.53; CI, 95%, 0.41–0.70; 1-sided p<0.0001) and reduced the risk of death by 35% (HR 0.65; 95% CI, 0.48-0.89; 1-sided p=0.0029).1
The safety profile was consistent with the known profiles of the individual medicines, and no new safety signals were observed.1 Grade ≥3 adverse events due to any cause occurred in 75.7% of patients treated with perioperative enfortumab vedotin plus pembrolizumab compared to 67.2% of patients treated with neoadjuvant chemotherapy.1
Results from the trial were recently published in The New England Journal of Medicine.1
Bladder cancer affects an estimated 200,000 people in Europe each year, with the region reporting the highest global incidence rates – particularly in Southern and Western Europe.2,3 MIBC accounts for approximately 30% of bladder cancer cases and is an advanced, aggressive form of the disease, in which cancer cells have entered the muscle wall of the bladder – increasing the risk that the disease will spread to other parts of the body if not treated effectively.4
Enfortumab vedotin plus pembrolizumab was approved by the European Commission (EC) in June 2026 as neoadjuvant and adjuvant treatment for cisplatin-ineligible adults with resectable MIBC. Approval in this setting would extend that indication to cisplatin-eligible patients, collectively covering adults with resectable MIBC regardless of cisplatin eligibility.
The EC is expected to issue a final decision on the application for enfortumab vedotin plus pembrolizumab within approximately two months. If approved, the EC’s decision will apply to all 27 European Union member states, as well as Iceland, Liechtenstein and Norway.
Astellas has already reflected the impact of the CHMP’s opinion in its financial forecast for the current fiscal year ending March 31, 2027.
About PADCEV (enfortumab vedotin)
PADCEV (enfortumab vedotin) 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.5 Nonclinical 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).5
Enfortumab vedotin in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph is approved as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) regardless of eligibility for cisplatin-containing chemotherapy in the United States. In the European Union (EU), enfortumab vedotin in combination with pembrolizumab is approved as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adult patients with resectable MIBC who are ineligible for cisplatin-based chemotherapy.
Additionally, enfortumab vedotin plus pembrolizumab is approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) regardless of cisplatin eligibility in the United States, Japan, and a number of other countries around the world. In the EU, the combination is approved for the treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy.
About the EV-304/KEYNOTE-B15 Trial
The EV-304 trial is an ongoing, open-label, randomized, controlled, Phase 3 study evaluating neoadjuvant and adjuvant enfortumab vedotin in combination with pembrolizumab versus neoadjuvant chemotherapy (gemcitabine and cisplatin) in patients with MIBC who are eligible for cisplatin-based chemotherapy. Patients were randomized to receive either neoadjuvant and adjuvant (before and after surgery) enfortumab vedotin in combination with pembrolizumab (arm A) or neoadjuvant chemotherapy (arm B). Curative-intent surgery (cystectomy) was performed in both arms. Enfortumab vedotin in combination with pembrolizumab was administered as a planned total of 9 cycles of enfortumab vedotin and 17 cycles of pembrolizumab, split before and after surgery.
The primary endpoint of this trial is EFS, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes RC or failure to undergo RC in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence based on BICR or death due to any cause. Key secondary endpoints include OS and pCR rate. For more information on the global EV-304 trial, go to clinicaltrials.gov.
(Press release, Astellas, SEP 18, 2026, View Source [SID1234670920])