Merck (MRK) said on Friday that the European Medicines Agency's Committee recommended approval of Keytruda, combined with Pfizer (PFE) and Astellas Pharma's Padcev, for first-line treatment of adults with unresectable or metastatic urothelial carcinoma.
The recommendation is based on data from the first interim analysis of the Phase 3 study conducted in collaboration with Pfizer and Astellas.
The study showed that Keytruda plus Padcev demonstrated statistically significant and clinically meaningful improvements in overall survival and progression-free survival in patients compared to platinum-based chemotherapy.
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