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FDA Approves Avelumab/Axitinib for Frontline RCC

Gina Columbus @ginacolumbusonc
Published: Wednesday, May 15, 2019

The FDA has approved the combination of avelumab (Bavencio) and axitinib (Inlyta) for the frontline treatment of patients with advanced renal cell carcinoma.1

Moreover, the European Medicines Agency validated a Type II variation application for the combination of avelumab and axitinib in advanced RCC in March 2019. A supplemental application for the combination for patients with unresectable or metastatic RCC was submitted in Japan in January 2019.


  1. FDA Approves Bavencio (Avelumab) Plus Inlyta (Axitinib) Combination for Patients With Advanced Renal Cell Carcinoma. Pfizer Oncology. Published May 14, 2019. Accessed May 14, 2019. 
  2. Motzer RJ, Penkov K, Hannen JBAG, et al. JAVELIN Renal 101: a randomized, phase III study of avelumab + axitinib vs sunitinib as first-line treatment of advanced renal cell carcinoma (aRCC). In: Proceedings from the 2018 ESMO Congress; October 19-23, 2018; Munich, Germany. Abstract LBA6_PR. 

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