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17-05-2019 | FDA | News

approvalsWatch

USA approves first-line avelumab–axitinib for advanced RCC

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medwireNews: US patients with treatment-naïve advanced renal cell carcinoma (RCC) may now be given the PD-L1 inhibitor avelumab in combination with the VEGFR inhibitor axitinib.

The FDA decision to approve the regimen follows the JAVELIN Renal 101 trial’s demonstration of significantly better progression-free survival and objective response rates compared with the multi-target receptor tyrosine kinase inhibitor sunitinib.

The recommended treatment schedule is avelumab 800 mg by intravenous fusion every 2 weeks alongside oral daily axitinib 5 mg, with hepatotoxicity and major cardiac adverse events among the reported adverse events.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group

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