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FDA Grants Breakthrough Therapy Designation to Astellas and Seattle Genetics Therapy in Combination with Merck Therapy

Astellas and Seattle Genetics, a biotechnology company dedicated to developing and commercializing monoclonal antibody therapies for the treatment of cancer, announced on Feb. 19, 2020 that FDA has granted breakthrough therapy designation to padcev (enfortumab vedotin-ejfv) in combination with Merck’s anti-PD-1 therapy keytruda (pembrolizumab) for treating patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting.

The combination was granted breakthrough therapy designation after receiving promising results during a phase 1b/2 trial for patients with locally advanced or metastatic urothelial cancer, according to an Astellas press release.

“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, MD, PhD, senior vice president and Oncology Therapeutic Area head, Astellas, in the press release. “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,” added Roger Dansey, MD, chief medical officer, Seattle Genetics, in the press release. “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.”