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EU Panel Backs Avelumab/Axitinib Combo for Frontline RCC

Gina Columbus @ginacolumbusonc
Published: Friday, Sep 20, 2019

Luciano Rossetti, head of Global R&D for EMD Serono

Luciano Rossetti

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion to recommend approval of the combination of avelumab (Bavencio) and axitinib (Inlyta) for the frontline treatment of adult patients with advanced renal cell carcinoma (RCC).1

In May 2019, the FDA approved the combination of avelumab and axitinib in the frontline setting for patients with advanced renal cell carcinoma, also based on the JAVELIN Renal 101 data.

References  

  1. CHMP Adopts Positive Opinion for BAVENCIO® (avelumab) Plus Axitinib for First-Line Treatment of Patients with Advanced Renal Cell Carcinoma. EMD Serono. Published September 20, 2019. https://bit.ly/2msbMrX. Accessed September 20, 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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