FDA approves first-line nivolumab–cabozantinib for advanced RCC
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.
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