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.
Related Links Eisai’s lenvatinib to get speedy review in Europe 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.
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