Merck KGaA said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, has given a positive opinion recommending approval of bladder-cancer treatment Bavencio, which it developed in a partnership with Pfizer Inc.
The German pharmaceuticals-and-chemicals company said that the European Commission will review the agency's opinion and that a decision is expected in early 2021.
The drug was given a recommendation for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma, or bladder cancer, Merck said. Bavencio is an immunotherapy which was proven to prolong overall survival in patients suffering from that type of cancer during a phase 3 trial.
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