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European Commission approves bladder cancer treatment
The European Commission has approved the combination of pembrolizumab (Keytruda) and enfortumab vedotin (Padcev) for the perioperative treatment of resectable muscle-invasive bladder cancer (MIBC) in adults. This authorization allows the therapies to be used as neoadjuvant treatment before radical cystectomy and as adjuvant treatment following surgery.
The approval is significant as it provides a treatment option for patients regardless of their eligibility for cisplatin-based chemotherapy, a group that includes approximately 50% of patients. The decision follows positive assessments from the European Medicines Agency and is based on the Phase III KEYNOTE-B15/EV-304 study. In this trial, the combination therapy lowered the risk of disease recurrence, progression, or death by 47% compared to neoadjuvant cisplatin and gemcitabine chemotherapy.
The regulatory clearance covers all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. Local availability will depend on individual country reimbursement processes.
Entities
Astellas · European Commission · European Medicines Agency · Keytruda · MSD · Merck & Co. · Padcev · Pfizer
Claims
What the coverage asserts, and how many sources carry each claim.
- [● 3 SOURCES] The treatment is intended for use as both neoadjuvant and adjuvant therapy. www.pharmaceutical-business-review.com · mantovauno.it
- [○ 1 SOURCE] The 24-month event-free survival (EFS) rate was 71.2% with enfortumab vedotin plus pembrolizumab versus 54.2% with chemotherapy among patients with detectable ctDNA at baseline. www.cancernetwork.com
- [○ 1 SOURCE] ctDNA clearance before surgery was higher with enfortumab vedotin plus pembrolizumab than with cisplatin and gemcitabine. www.cancernetwork.com
- [○ 1 SOURCE] The approval covers all 27 EU member states, Iceland, Liechtenstein, and Norway. www.pharmaceutical-business-review.com
- [○ 1 SOURCE] The combination therapy lowered the risk of disease recurrence, progression, or death by 47% compared to cisplatin and gemcitabine chemotherapy. www.pharmaceutical-business-review.com
- [● 5 SOURCES] The European Commission approved pembrolizumab and enfortumab vedotin for resectable muscle-invasive bladder cancer. mantovauno.it · www.pharmaceutical-business-review.com · cn24tv.it
- [● 2 SOURCES] The treatment is applicable to patients regardless of cisplatin eligibility. mantovauno.it · www.pharmaceutical-business-review.com
- [● 2 SOURCES] The therapy is available to patients regardless of cisplatin eligibility. mantovauno.it · www.pharmaceutical-business-review.com