MedPath
EMA Product

Lenvima

Product approved by European Medicines Agency (EU)

Basic Information

Lenvima

Regulatory Information

EMEA/H/C/003727

Authorised

May 28, 2015

March 26, 2015

26

September 17, 2024

Company Information

Germany

Edmund-Rumpler-Straße 3 60549 Frankfurt am Main

Eisai GmbH

Drug Classification

Accelerated Assessment

Active Substances Detail

lenvatinib mesilate

Detailed Information

Therapeutic Indication

### Therapeutic indication Lenvima is indicated as monotherapy for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). Lenvima is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy.

Overview Summary

Lenvima is a cancer medicine used to treat adults with: - differentiated thyroid carcinoma, a type of cancer originating from the follicular cells of the thyroid gland. Lenvima is used on its own when the cancer has progressed or spread locally or to other parts of the body, and does not respond to treatment with radioactive iodine; - hepatocellular carcinoma (a type of liver cancer). It is used on its own in patients who did not previously receive a cancer medicine by mouth or by injection and whose cancer is advanced or cannot be removed by surgery; - endometrial carcinoma (cancer of the lining of the womb). It is used together with another cancer medicine, pembrolizumab, in patients whose disease is advanced or has come back after previous treatment involving platinum-based cancer medicines, when surgery or radiation to cure the cancer is not possible. Lenvima contains the active substance lenvatinib.

© Copyright 2025. All Rights Reserved by MedPath