KENILWORTH (NJ) (dpa-AFX) - Merck & Co Inc.(MRK) announced that the European Commission approved KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) as perioperative treatment for adults with resectable muscle-invasive bladder cancer, regardless of cisplatin eligibility.
The approval was based on the Phase 3 KEYNOTE-B15 trial, where the combination reduced the risk of event-free survival events by 47% and the risk of death by 35% compared with chemotherapy and surgery in cisplatin-eligible patients.
The trial also showed a pathological complete response rate of 55.8% with the combination, compared with 32.5% with chemotherapy.
The approval covers all 27 EU member states, as well as Iceland, Liechtenstein and Norway.
The stock closed Tuesday's trade at $148.30, up 3.25%. In the Premarket trading, the stock is trading at $147.65, down 0.44%.
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