FDA approves Keytruda and Padcev combo for bladder cancer treatment

The Food and Drug Administration approved a combination treatment of pembrolizumab (Keytruda, Merck) and enfortumab vedotin-ejfv (Padcev, Astellas Pharma) for adults with muscle invasive bladder cancer who cannot receive cisplatin chemotherapy.

The approval covers both neoadjuvant treatment before surgery and adjuvant treatment after cystectomy. The FDA also approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) with enfortumab vedotin-ejfv for the same indication.

The approval was based on results from the KEYNOTE-905/EV-303 trial, which studied 344 patients with previously untreated muscle invasive bladder cancer. Patients received either the combination treatment before and after surgery or underwent immediate surgery alone.

The trial showed statistically significant improvements in event-free survival and overall survival for patients receiving the combination treatment. Median event-free survival was not reached in the combination arm compared to 15.7 months in the surgery-only arm. The hazard ratio was 0.40 with a p-value of less than 0.0001.

For overall survival, the median was not reached in the combination arm versus 41.7 months in the surgery-only arm, with a hazard ratio of 0.50 and a p-value of 0.0002.

The recommended neoadjuvant dosage is pembrolizumab 200 mg intravenously every three weeks combined with enfortumab vedotin-ejfv 1.25 mg/kg on days 1 and 8 of a 21-day cycle for three cycles. In the adjuvant phase, enfortumab vedotin-ejfv continues for six additional cycles with pembrolizumab.

The FDA conducted this review under Project Orbis, collaborating with regulatory agencies in Australia, Canada, Switzerland, and the United Kingdom. The application received priority review and was approved five months ahead of the FDA goal date.

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