Astellas Pharma Inc. and Seagen Inc., announced that the U.S. FDA has granted PADCEV (enfortumab vedotin-ejfv) with KEYTRUDA (pembrolizumab) accelerated approval in the U.S. as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) who are not eligible to receive cisplatin-containing chemotherapy.

The indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in the EV-302 confirmatory trial.

“The accelerated approval for the combination of PADCEV and pembrolizumab marks an important milestone for the approximately 8,000 to 9,000 patients in the United States with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy,” said Ahsan Arozullah, senior vice president, head of oncology development, Astellas. “This patient population now has an additional treatment option to treat advanced bladder cancer at first diagnosis of metastatic disease.”

“Advanced-stage urothelial cancer is aggressive and associated with devastating outcomes,” said David Epstein, CEO, Seagen. “In the EV-103 clinical trial, the use of PADCEV in combination with pembrolizumab resulted in confirmed and durable tumor responses in over two-thirds of patients with advanced bladder cancer. Global enrollment in the confirmatory trial, EV-302, is complete. With this approval, we look forward to providing a new treatment option that helps address a high unmet need for these patients.”

The approval is based on objective response rates (ORR) and median duration of response (DOR) in combined Dose Escalation/Cohort A and Cohort K of the phase 1b/2 EV-103 trial (NCT03288545, also known as KEYNOTE-869).