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Pfizer : FDA Oks BAVENCIO Plus INLYTA Combination For Patients With Advanced RCC

EMD Serono, the biopharmaceutical business of Merck KGaA (MKGAY.PK), and Pfizer Inc. (PFE) said that the US Food and Drug Administration has approved BAVENCIO or avelumab in combination with INLYTA or axitinib for the first-line treatment of patients with advanced renal cell carcinoma or RCC.

RCC is a type of cancer where PD-L1 expression may contribute to inhibition of the immune response against the tumor. It is also a highly vascular tumor, in which vascular endothelial growth factor (VEGF) plays a key role.

The European Medicines Agency validated the Type II variation application for BAVENCIO in combination with INLYTA in advanced RCC in March 2019, and a supplemental application for BAVENCIO in combination with INLYTA in unresectable or metastatic RCC was submitted in Japan in January 2019.

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