The indications for lenvatinib have been extended. It is now indicated, in combination with pembrolizumab, for the first-line treatment of adults with advanced renal cell carcinoma.

A phase 3 trial investigated the efficacy of this therapy in patients with advanced renal cell carcinoma and no previous systemic therapy. Patients were randomly assigned to receive lenvatinib (20mg daily) plus pembrolizumab (200mg every three weeks), lenvatinib (18mg daily) plus everolimus (5mg daily), or sunitinib (50mg daily, alternating four weeks on and two weeks off treatment). Median progression-free survival was longer in the lenvatinib groups (23.9 months when combined with pembrolizumab and 14.7 months with everolimus) compared to the sunitinib group (9.2 months). Overall survival was also longer for lenvatinib plus pembrolizumab, but was not longer for lenvatinib plus everolimus compared to sunitinib.

Adverse events most commonly reported in the lenvatinib plus pembrolizumab group include diarrhoea (61.4%), hypertension (55.4%), hypothyroidism (47.2%), and reduced appetite (40.3%). Grade 3 or higher adverse events occurred in 82.4% of patients, with hypertension and diarrhoea most common. The product information provides recommendations for the management of adverse reactions, including dose modification and treatment discontinuation.

Lenvatinib is not currently subsidised on the Pharmaceutical Benefits Scheme (PBS) for the treatment of renal cell carcinoma.


  1. Lenvima® (Lenvatinib) Australian approved product information. Melbourne: Eisai. Approved January 2016.
  2. Motzer R, Alekseev B, Rha SY, Porta C, Eto M, Powles T, et al. Lenvatinib plus pembrolizumab or everolimus for advanced renal cell carcinoma. N Engl J Med. 2021; 384: 1289-1300.

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