Trials & Filings

Astellas Achieves Breakthrough Designation for Urothelial Cancer ADC

Enfortumab vedotin is being evaluated in metastatic urothelial cancer in patients previously treated with CPIs

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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 enfortumab vedotin, an antibody-drug conjugate (ADC), for locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors (CPI). Breakthrough Therapy Designation aims to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition and may offer substantial improvement over available therapy. ...

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