WASHINGTON – The Food and Drug Administration on Friday approved a new drug for hard-to-treat thyroid cancer, two months ahead of schedule.
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The drug, Lenvima, from Japanese drugmaker Eisai is intended for patients with differentiated thyroid cancer that has spread despite radiation treatment. The drug works by blocking proteins that help cancer cells grow and divide. About 1,900 U.S. patients died of thyroid cancer in 2014, according to an estimate from the National Cancer Institute.
The FDA approved the drug ahead of its April 14 review target, under an expedited review program for drugs that provide significant improvement in safety and effectiveness.
In a 392-patient study, Lenvima halted the growth of thyroid cancer for 18.3 months, compared with 3.6 months in patients receiving a placebo. Additionally, Lenvima shrank tumors in 65 percent of patients getting the drug.
The drug's side effects include heart failure, blood clots, liver damage, kidney damage, headache, confusion and seizures.
Eisai Co. Ltd. Is based in Tokyo. It sells the weight loss pill Belviq in the U.S. and many other countries under a partnership with Arena Pharmaceuticals, based in San Diego.