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Industry News Archive

FDA Grants Regular Approval + New Indication to Enfortumab Vedotin-ejfv

On July 9, 2021, Astellas Pharma Inc. and Seagen Inc. announced that the U.S. Food and Drug Administration (FDA) has granted regular approval to enfortumab vedotin-ejfv. The FDA also approved a new indication for enfortumab vedotin-ejfv for adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and who have previously received one or more prior lines of therapy.

Read the FDA announcement.

Read the SeaGen announcement.

Posted 7/9/2021

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