Bavencio wins EU approval in advanced RCC

29 October 2019

Merck KGaA (MRK: DE) and Pfizer’s (NYSE: PFE) entry into the PD-L1 space has secured a European Commission approval in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

The approval of the Bavencio (avelumab) combination comes nearly six months after it was approved by the US Food and Drug Administration in this indication.

Positive interim results from the Phase III JAVELIN Renal 101 study helped to secure the approval, demonstrating that Bavencio and axitinib significantly lowered risk of disease progression or death by 31% compared with sunitinib in patients with advanced RCC regardless of PD-L1 status.

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