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FDA Grants Avelumab/Axitinib Combo Priority Review for RCC

Gina Columbus @ginacolumbusonc
Published: Tuesday, Feb 12, 2019

Chris Boshoff, MD, PhD

Chris Boshoff, MD, PhD
The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) for the combination of avelumab (Bavencio) and axitinib (Inlyta) as a treatment for patients with advanced renal cell carcinoma (RCC).1

The decision is based on findings from the pivotal phase III JAVELIN Renal 101 trial, which were presented at the 2018 ESMO Congress. Results showed that the combination significantly improved progression-free survival (PFS) and doubled the objective response rates (ORR) when compared with sunitinib (Sutent) in patients with treatment-naïve advanced RCC, regardless of PD-L1 expression.2

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