2 Information about lenvatinib

Marketing authorisation indication

2.1 Lenvatinib (Lenvima, Eisai) is indicated as monotherapy for 'the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy'.

Dosage in the marketing authorisation

2.2 The daily dose of lenvatinib in the summary of product characteristics is 8 mg (2×4 mg capsules) given orally for patients who weigh less than 60 kg, and 12 mg (3×4 mg capsules) orally for patients who weigh 60 kg or over (based on company submission). The summary of product characteristics advises that dose adjustments are not needed on the basis of hepatic function in people with Child–Pugh grade A liver impairment. It advises that the available data are not sufficient to make a dosing recommendation for people with Child–Pugh grade B liver impairment; safety should be closely monitored in these patients. Because lenvatinib has not been studied in patients with Child–Pugh grade C liver impairment, the summary of product characteristics does not advise use in these patients.


2.3 £1,437 for 30×4 mg capsules (excluding VAT; British national formulary [BNF] online [accessed May 2018]). The company has a commercial agreement (patient access scheme). This makes lenvatinib available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.

  • National Institute for Health and Care Excellence (NICE)