Astellas Pharma Inc. and Seattle Genetics, Inc. were granted Breakthrough Therapy designation by the FDA for PADCEV (enfortumab vedotin-ejfv) in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting.

The FDA’s Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition. It’s based on preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over available therapies.

The designation was based on results from a dose-escalation cohort from an ongoing Phase Ib/II trial, EV-103 evaluating patients with locally advanced or metastatic urothelial cancer.

“The FDA’s Breakthrough Therapy designation reflects the encouraging preliminary evidence for the combination of PADCEV and pembrolizumab in previously untreated advanced urothelial cancer to benefit patients who are in need of effective treatment options,” said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head, Astellas. “We look forward to continuing our work with the FDA as we progress our clinical development program as quickly as possible.”

“This is an important step in our investigation of PADCEV in combination with pembrolizumab as a first-line therapy for patients with advanced urothelial cancer who are unable to receive cisplatin-based chemotherapy,” said Roger Dansey, M.D., Chief Medical Officer, Seattle Genetics. “Based on encouraging early clinical activity, we recently initiated a phase 3 trial of this platinum-free combination and look forward to potentially addressing an unmet need for patients.”