FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EU Approves Merck and Pfizer’s Bavencio for Common Form of Kidney Cancer

Nov. 8, 2019
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The European Commission approved Bavencio (avelumab) in combination with Pfizer’s Inlyta (axitinib) for first-line treatment of adult patients with advanced renal cell carcinoma (RCC), the most common form of kidney cancer.

The approval was based on the results of a phase 3 clinical trial, which showed that the combination treatment significantly lowered the risk of disease progression or death by 31 percent, and nearly doubled the response rate compared with sunitinib in patients with advanced RCC regardless of PD-L1 status.

The FDA granted its approval for the combination as a first-line treatment for patients with advanced RCC in May.

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