The FDA on Friday granted full approval to Seagen and Astellas Pharma’s Padcev (enfortumab vedotin-ejfv) in combo with Merck’s Keytruda (pembrolizumab) for patients with locally advanced or metastatic urothelial cancer.
The approval comes a little less than two months after thousands of ESMO delegates in October gave a standing ovation to confirmatory trial data showing the Padcev-Keytruda combination is the “new standard of care” in first-line bladder cancer.
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