FDA Breakthrough Therapy granted to bladder cancer treatment

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for PADCEV™ (enfortumab vedotin-ejfv) in combination with anti-PD-1 therapy Keytruda^® (pembrolizumab), it has been announced by Astellas and Seattle Genetics.

This is for the treatment of patients with 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 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 Dr Andrew Krivoshik, 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 firstline therapy for patients with advanced urothelial cancer who are unable to receive cisplatin-based chemotherapy,” added Dr Roger Dansey, Chief Medical Officer, Seattle Genetics. “Based on encouraging early clinical activity, we recently initiated a Phase III trial of this platinum-free combination and look forward to potentially addressing an unmet need for patients.”

The Breakthrough Therapy designation was granted based on results from the dose-escalation cohort and expansion cohort A of the Phase Ib/II trial, EV-103, evaluating patients with locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy treated in the first-line setting with PADCEV in combination with pembrolizumab.

The FDA’s Breakthrough Therapy process is designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition. Designation is based upon preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints.