Fda grants priority review for supplemental biologics license application (sbla) of padcev® (enfortumab vedotin-ejfv) with keytruda® (pembrolizumab) for first-line treatment of advanced bladder cancer
– results of pivotal confirmatory trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall survival and progression-free survival vs standard platinum containing chemotherapy– – if approved, the combination would be the first and only antibody-drug conjugate plus pd-1 inhibitor treatment alternative to chemotherapy in this patient population – tokyo and bothell, wash. , nov. 30, 2023 /prnewswire/ -- astellas pharma inc. (tse:4503, president and ceo: naoki okamura, "astellas") and seagen inc. (nasdaq: sgen) today announced that on november 30, 2023 the u.s. food and drug administration (fda) accepted for priority review a supplemental biologics license application (sbla) for padcev® (enfortumab vedotin-ejfv) with keytruda® (pembrolizumab) as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/muc), a form of bladder cancer that has spread to surrounding organs or muscles, or other parts of the body.
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