FDA Grants Breakthrough Therapy Designation for Padcev in Combination with Pembrolizumab in FirstLine Advanced Bladder Cancer

FDA Grants Breakthrough Therapy Designation for Padcev in Combination with Pembrolizumab in First-Line Advanced Bladder Cancer

14:17 EST 19 Feb 2020 | Speciality Pharma Journal

BOTHELL, Wash. & TOKYO–(BUSINESS WIRE)–Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for PADCEV™ (enfortumab vedotin-ejfv) in combination with Merck’s (known as MSD outside the United States and Canada) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the treatment …

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