EMA Recommends Extension of Indications for Lenvatinib

New indication concerns first-line treatment of advanced or unresectable hepatocellular carcinoma

On 28 June 2018, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product lenvatinib (Lenvima). 

The marketing authorisation holder for this medicinal product is Eisai Europe Ltd. 

The CHMP adopted a new indication and made a change to the existing indication. 

New indication concerns a monotherapy in the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have received no prior systemic therapy. 

The CHMP recommended a change for existing indication by specifying that lenvatinib is indicated as monotherapy for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine. 

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission. 

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.