Eisai has filed its anticancer agent lenvatinib with regulators on both sides of the Atlantic.
Specifically the drug has been submitted as a treatment for progressive radioiodine-refractory, differentiated thyroid cancer. The filings, which come after a Japanese submission in June, is based on a 392-patient Phase III study which showed that lenvatinib achieved a statistically significant improvement in progression-free survival.
Lenvatinib has orphan drug designation for thyroid cancer in the USA, Japan and in Europe, where it has granted an accelerated assessment by the European Medicines Agency, as a new medicine expected to be of major public health interest.
Lenvatinib is an oral multiple receptor tyrosine kinase inhibitor and if all goes well with regulators it would be a first-in-class treatment for thyroid cancer. The drug is also being studied for hepatocellular carcinoma (Phase III), non-small cell lung cancer (Phase II) and other solid tumour types.
