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26-01-2021 | Oncology | News | Article

approvalsWatch

FDA approves first-line nivolumab–cabozantinib for advanced RCC

Author:
Lynda Williams

medwireNews: The US FDA has approved the use of nivolumab plus cabozantinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

The decision is based on findings from the open-label CheckMate 9ER trial demonstrating a significant improvement in both survival outcomes and the overall response rate with the PD-1 inhibitor and multitargeted tyrosine kinase inhibitor combination compared with sunitinib monotherapy.

The recommended dosing is nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks plus cabozantinib 40 mg once daily until unacceptable toxicity or disease progression. Adverse events associated with the combination include diarrhea, fatigue, liver toxicity, and other gastrointestinal side effects.

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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