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The Food and Drug Administration (FDA) in the United States has approved the avelumab (Bavencio) plus axitinib (Inlyta) combination for first-line treatment of advanced renal cell carcinoma (RCC).
The approval is the first by the FDA for an anti-PD-L1 therapy as part of a combination treatment for patients with advanced RCC. Around 20-30% of people are diagnosed with advanced RCC, and 30% of people treated for early stage RCC go on to develop advanced disease. This highlights the significant unmet need for effective first-line treatments that delay disease progression and are tolerable for patients.
The approval is based on the results from the open-label phase 3 JAVELIN Renal 101 study involving 886 patients. In this study, median progression-free survival was extended by more than 5 months compared with sunitinib.
The avelumab plus axitinib combination is currently being reviewed by the European Medicines Agency (EMA) for use within Europe.