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FDA Approves Astellas and Seagen’s PADCEV with KEYTRUDA Combo

First treatment option combining an antibody-drug conjugate plus a PD-1 inhibitor in urothelial cancer.

Astellas Pharma Inc. and Seagen Inc., announced that the U.S. FDA has granted PADCEV (enfortumab vedotin-ejfv) with KEYTRUDA (pembrolizumab) accelerated approval in the U.S. as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) who are not eligible to receive cisplatin-containing chemotherapy. The indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval fo...

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