FDA Approves Lenvima for Differentiated Thyroid Cancers

February 17, 2015
BioPharm International Editors

FDA announced that it approved Lenvima to treat patients with differentiated thyroid cancer after it was submitted under a priority review and orphan drug programs.

 

FDA announced on Feb. 13, 2015 that it approved Lenvima (lenvatinib) for the treatment of progressive, differentiated thyroid cancer (DTC). The drug was approved for patients whose disease had progressed after receiving radioactive iodine therapy (radioactive iodine refractory disease).

According to the National Cancer Institute, 62,980 Americans were diagnosed with thyroid cancer in 2014, of that number 1890 died. The American Cancer Society explains that the cells in types of DTCs look like normal thyroid tissues under a microscope, and develop from thyroid follicular cells. Lenvima, a kinase inhibitor, blocks certain proteins from helping cancer cells grow and divide. Its efficacy was demonstrated in 392 patients who were randomly assigned Lenvima or a placebo. Sixty-five percent of patients treated with Lenvima saw a reduction in tumor size and lived a median 18.3 months with disease progression, versus 2% with size reduction and a median of 3.6 months for patients receiving the placebo.

Lenvima was reviewed under FDAs priority review program, and previously received orphan product designation in February 2013. This approval comes two months before its estimated user fee goal date of April 2015. Lenvima is marketed by the New Jersey-based branch of Eisai, which is a Japanese research and development company.

Sources:
FDAAmerican Cancer SocietyPR Newswire