Merck KGaA, Pfizer's Bavencio set to seal bladder cancer approval after confirmatory trial scores
Bavencio could use the win.
More than two years after its makers — Germany’s Merck KGaA and Pfizer — secured FDA approval for a form of bladder cancer, the companies unveiled that the confirmatory study testing the PD-L1 inhibitor had performed as expected, helping patients live longer as a maintenance treatment versus standard-of-care.
The drug was granted accelerated approval on the basis of tumor response and duration of response in May 2017 in patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has progressed during or after platinum-containing chemotherapy. On Monday, the companies said that data from the confirmatory JAVELIN Bladder 100 trial showed patients treated with Bavencio lived significantly longer than those who received standard care.
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