The immunotherapy drug avelumab (Bavencio) has been designated a breakthrough therapy by the US Food and Drug Administration (FDA) for the second time, this time for use in combination with axitinib (Inlyta) for people with advanced renal cell carcinoma (RCC) who have received no previous treatment.

The breakthrough therapy designation speeds up the development and review of medicines that target serious or life-threatening conditions and have the potential to offer substantial benefit over existing therapies. The FDA awarded breakthrough therapy status based on a preliminary evaluation of clinical data from the JAVELIN Renal 100 clinical trial, a global phase Ib study assessing the safety and efficacy of the avelumab plus axitinib combination in RCC.

Findings from the JAVELIN Renal 100 study show that combining the PD-L1 inhibitor avelumab with the VEGF inhibitor axitinib induced a response in 58.2 % of patients with advanced RCC.


Avelumab is approved in the US and EU under the trade name Bavencio to treat Merkel cell carcinoma, and also in the US for urothelial carcinoma.

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