Padcev and Keytruda Combination Approved for Urothelial Cancer

The FDA has granted Accelerated Approval to Astellas Pharma and Seagen’s Padcev (enfortumab vedotin-ejfv) in combination with Merck’s Keytruda (pembrolizumab) for treatment of adults with locally advanced or metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy.

The agency decision was based on trial results that showed a durable tumor response. In one clinical study, the combination therapy showed a response rate of 68 percent, with a complete response in 12 percent of participants.

A full approval for the indication will depend on a verification of the clinical benefit in a confirmatory trial.

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