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02-03-2021 | EMA | News

approvalsWatch

Cabozantinib–nivolumab receives EMA positive opinion for advanced RCC

Author:
Lynda Williams

medwireNews: Cabozantinib plus nivolumab has been given the EMA go-ahead as a first-line treatment for European patients with advanced renal cell carcinoma (RCC).

The combination has been granted a positive opinion extending cabozantinib’s use beyond that as a monotherapy for treatment-naïve RCC with an intermediate or poor prognosis or for RCC after vascular endothelial growth factor inhibitor therapy.

The EMA’s decision follows that of the US FDA who approved first-line cabozantinib plus nivolumab for advanced RCC in January 2021 on the basis of the CheckMate 9ER trial results. The study showed survival benefits with the combination versus sunitinib in this patient population.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group

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