FDA Grants Frontline Avelumab/Axitinib Breakthrough Designation for RCC

December 21, 2017 – The FDA has granted the PD-L1 inhibitor avelumab a breakthrough therapy designation for use in combination with the VEGF inhibitor axitinib in treatment-naïve patients with advanced renal cell carcinoma (RCC). The designation, which will expedite the development and review of this combination, is based on findings from the phase Ib JAVELIN Renal 100 trial. In the study, frontline avelumab/axitinib induced a response rate of … (leggi tutto)