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16-08-2021 | FDA | News

approvalsWatch

Lenvatinib–pembrolizumab gets FDA nod for first-line advanced RCC

Author:
Shreeya Nanda

medwireNews: The US FDA has approved the combination of lenvatinib and pembrolizumab for treatment-naïve adult patients with advanced renal cell carcinoma (RCC).

The decision follows on from the positive results of the CLEAR trial, which demonstrated a significant improvement in progression-free survival and overall survival with lenvatinib–pembrolizumab versus sunitinib. The objective response rate was also significantly higher with the combination than sunitinib.

The FDA recommends that lenvatinib be given orally at a dose of 20 mg/day, with pembrolizumab administered intravenously over 30 minutes either at a dose of 200 mg every 3 weeks or 400 mg every 6 weeks for up to 2 years.

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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