MKGAY - Merck-Pfizer win positive opinion from EU for cancer therapy

EMD Serono, the biopharma arm of Merck KGaA (MKGAY) and Pfizer Inc. (PFE) today announced that the European Medicines Agency has formed a positive opinion, recommending the approval of BAVENCIO® (avelumab), an antibody-based cancer therapy against urothelial carcinoma jointly developed and commercialized by the companies.The positive opinion recommends the drug as a monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are progression-free following platinum-based chemotherapy.The endorsement, which was based on positive findings from the Phase III JAVELIN Bladder 100 trial, will be reviewed by the European Commission with a decision expected in early 2021, the companies said. The results of the trial appeared in The New England Journal of Medicine in September.The treatment has already won FDA approval in June 2020 as a maintenance treatment for patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy.“The overall survival

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Merck-Pfizer win positive opinion from EU for cancer therapy