FDA approves Keytruda + Padcev for first-line treatment of certain patients with locally advanced or metastatic urothelial cancer

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FDA approved Keytruda (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. 

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Results of a sub-study of the phase III CheckMate-901 trial showed that Opdivo (nivolumab) in combination with cisplatin-based chemotherapy followed by Opdivo monotherapy demonstrated statistically significant benefits in OS and PFS compared to standard-of-care cisplatin-based combinations as a first-line treatment for patients with unresectable or metastatic urothelial carcinoma who are eligible for cisplatin-based chemotherapy. 

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