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29-04-2019 | FDA | News

approvalsWatch

FDA approves first-line pembrolizumab–axitinib for advanced RCC

medwireNews: US patients with treatment-naïve advanced renal cell carcinoma (RCC) may now be treated with pembrolizumab plus axitinib following FDA approval of the regimen.

The announcement follows interim results from the KEYNOTE-426 trial demonstrating significant overall and progression-free survival benefits with the PD-1 inhibitor given in combination with the tyrosine kinase inhibitor axitinib versus sunitinib monotherapy.

The combination is permitted regardless of tumor PD-L1 expression level. The recommended dosage is pembrolizumab 200 mg every 3 weeks alongside axitinib 5 mg twice daily.

Grade 3–4 liver toxicity has been reported in a fifth of patients, alongside side effects including gastrointestinal adverse events, fatigue, hypertension, hypothyroidism, and palmar–plantar erythrodysesthesia.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group

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