Avelumab plus axitinib granted FDA approval for advanced kidney cancer

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.

Read more in PharmaTimes here

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