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FDA Grants Frontline Avelumab/Axitinib Breakthrough Designation for RCC

Jason M. Broderick @jasoncology
Published: Thursday, Dec 21, 2017

Chris Boshoff, MD, PhD

Chris Boshoff, MD, PhD
The FDA has granted the PD-L1 inhibitor avelumab (Bavencio) a breakthrough therapy designation for use in combination with the VEGF inhibitor axitinib (Inlyta) in treatment-naïve patients with advanced renal cell carcinoma (RCC).

The majority of infusion-related reactions were grade 1 or 2 and occurred mainly during the first 2 infusions of avelumab. Seventeen patients experienced an immune-related AE, with only 3 being grade 3. Myocarditis was the only immune-related AE that led to death.
Choueiri TK, Larkin JMG, Oya M, et al. First-line avelumab + axitinib therapy in patients (pts) with advanced renal cell carcinoma (aRCC): results from a phase Ib trial. J Clin Oncol 35, 2017 (suppl; abstr 4504).

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