Lenvima (lenvatinib)
- Region
- 🇪🇺 EU
- Active substance
- lenvatinib
- Company
- Eisai GmbH
- Status
- Authorised
- Therapeutic area
- Thyroid Neoplasms
- CHMP opinion
- Thu 26 Mar 2015
- EU approval
- Thu 28 May 2015
- Designations
- Accelerated assessment
- Application
- EMEA/H/C/003727
- ATC
- L01XE
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Kisplyx Authorised · Eisai GmbH
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.