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26-04-2018 | FDA | Drug approval | News

approvalsWatch

FDA backs nivolumab plus ipilimumab for first-line advanced RCC

medwireNews: US patients with treatment-naïve, intermediate- or poor-risk, advanced renal cell carcinoma (RCC) can receive the combination of nivolumab and ipilimumab in the first line following an FDA decision.

In the CheckMate 214 trial – on which this decision is based – treatment with nivolumab plus ipilimumab reduced the risk for death by a significant 37% versus sunitinib therapy in patients with intermediate- or poor-risk disease. The corresponding median overall survival times were unreached and 25.9 months.

The objective response rate was also significantly better with the combination than sunitinib in these patients, at 41.6% and 26.5%, respectively.

The FDA recommends that nivolumab at a dose of 3 mg/kg should be followed by ipilimumab 1 mg/kg, both given on the same day every 3 weeks for four cycles, after which single-agent nivolumab should be administered either at a dose of 240 mg every 2 weeks or 480 mg every 4 weeks.

By Shreeya Nanda

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

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