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Merck KGaA, Pfizer: CHMP Recommends Approval Of BAVENCIO - Quick Facts

EMD Serono, the biopharmaceutical business of Merck KGaA (MKGAY.PK), and Pfizer Inc. (PFE) said Friday that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has adopted a positive opinion for BAVENCIO (avelumab).

The CHMP positive opinion recommends approval of BAVENCIO as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC), who are progression-free following platinum-based chemotherapy.

The CHMP positive opinion will now be reviewed by the European Commission or EC, with a decision expected in early 2021.

The CHMP positive opinion was based on positive findings from the Phase III JAVELIN Bladder 100 trial, results of which were published in the New England Journal of Medicine in September.

BAVENCIO is the only immunotherapy to significantly prolong overall survival or OS in locally advanced or metastatic UC in the first-line setting in a Phase III trial.

In June 2020, the U.S. Food and Drug Administration or FDA approved BAVENCIO for the maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy.

EMD Serono and Pfizer have submitted additional regulatory applications in Japan and other countries.

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