
The decision removes the triple-class–refractory requirement and allows melflufen use after at least 2 prior lines of therapy.
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The FDA granted priority review to perioperative enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for patients with cisplatin-eligible muscle-invasive bladder cancer based on which key finding from the phase 3 KEYNOTE-B15 trial (NCT04700124)?





