Lenvatinib Shows Positive Results in Clinical Trial — Lenvatinib Approval Sought from FDA09/2014
Lenvatinib Approval Sought from FDA
August 18, 2014— Eisai, the manufacturer of lenvatinib (E7080), has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for the use of lenvatinib to treat patients who have progressive, radioactive iodine (RAI)-refractory differentiated thyroid cancer (papillary, follicular, and variants).
The FDA review timeline will be set in mid-October, with the fastest possible decision to take place in 6 months.
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July 30, 2014— Lenvatinib, a new drug that has shown promise in a clinical trial for treating progressive differentiated thyroid cancer (papillary, follicular, and their variants) that does not respond to radioactive iodine, will receive accelerated assessment by the European Medicines Agency (EMA).
Lenvatinib is an oral multiple receptor tyrosine kinase (RTK) inhibitor. It is manufactured by Eisai.
Esai also reported that it soon plans to submit an application to the United States Food and Drug Administration (FDA) for Lenvantinib.
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Lenvatinib shows promising results as a treatment option for people with differentiated radioiodine-resistant thyroid cancer, according to a Phase III clinical trial reported at the meeting of the American Society of Clinical Oncology (ASCO).
Lead study author is Martin Schlumberger, M.D., Oncology Professor at University Paris Sud, France and ThyCa Medical Advisor.
A summary of the presentation at ASCO is here.