Seagen, astellas and merck announce fda acceptance of sblas for padcev® (enfortumab vedotin-ejfv) with keytruda® (pembrolizumab) for the first-line treatment of certain patients with locally advanced or metastatic urothelial cancer

Bothell, wash. & tokyo & rahway, n.j.--( business wire )--seagen inc. (nasdaq: sgen), astellas pharma inc. (tse:4503) and merck (nyse: mrk), known as msd outside of the united states and canada, today announced the u.s. food and drug administration (fda) has accepted for priority review supplemental biologics license applications (sblas) for padcev® (enfortumab vedotin-ejfv) and keytruda® (pembrolizumab) for use of these two agents in combination for the treatment of patients with locally advanced or metastatic urothelial cancer (la/muc) who are not eligible to receive cisplatin-containing chemotherapy. the respective applications are intended to expand both labels for padcev and keytruda. the agency set a prescription drug user fee act (pdufa) goal date for each application of april 21, 2023.
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