Eisai Submits Lenvatinib for US and European Regulatory Approval
Eisai have confirmed that they have submitted their anticancer agent, Lenvatinib, with regulatory agencies in both Europe and the US.
Specifically, Lenvatinib has been submitted for progressive radioiodine-refractory, differentiated thyroid cancer.
The regulatory submissions are based on a 392-patient Phase III clinical trial, which showed the drug achieved a statistically significant improvement in progression-free survival.
The drug has obtained orphan drug designation for thyroid cancer in the USA, Japan and in Europe, where it has been granted accelerated assessment by the European Medicines Agency.
In 2012 it was estimated that approximately 52,000 patients in the US and 53,000 people in Europe were newly diagnosed with thyroid cancer. Although treatment is possible for most types of thyroid cancer, there are few options once the cancer has progressed, meaning the disease still has significant unmet medical needs.
Lenvatinib is an oral multiple receptor tyrosine kinase inhibitor and if the drug were to receive regulatory approval, would be a first-in-class treatment for thyroid cancer. Lenvatinib is also currently being evaluated for hepatocellular carcinoma (Phase III), non-small cell lung cancer (Phase II) and other solid tumour types.