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Astellas, Seattle Genetics PADCEV Gains Breakthrough Designation

In combination with Merck's anti-PD-1 therapy KEYTRUDA for the treatment of advanced or metastatic urothelial cancer

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By: Kristin Brooks

Managing Editor, Contract Pharma

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 i...

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