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Merck KgaA : EU Approves Bavencio To Treat Locally Advanced Or Metastatic Urothelial Carcinoma

EMD Serono, the Healthcare business sector of Merck KgaA (MKGAY.PK), and Pfizer Inc. (PFE) said that the European Commission has approved Bavencio or avelumab as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma or UC who are progression-free following platinum-based chemotherapy.

Bavencio maintenance treatment significantly extended median overall survival versus standard of care in the Phase III JAVELIN Bladder 100 study.

Bavencio was first approved in the US as a first-line maintenance treatment for advanced urothelial carcinoma by the US Food and Drug Administration in June 2020 and is now approved for this indication in 38 countries. Additional regulatory applications are under review in 13 countries, including in Japan, where approval is expected in the first-half 2021.

Bavencio in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma.

Bavencio is currently approved for patients in 50 countries for at least one use.

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