Thyroid Cancer Drug Approved by FDA

(thyca.org)

16 February 2015. The U.S. Food and Drug Administration approved on Friday a drug for differentiated thyroid cancers, where the cancer continues to grow despite treatments with radioactive iodine. The drug, lenvatinib, is marketed by Eisai Inc. in Woodcliffe, New Jersey, under the brand name Lenvima.

The thyroid gland helps the body regulate metabolism, using iodine from the blood to make the needed hormones. Cells in the thyroid also generate hormones for controlling use of calcium in the body. Most cancers of the thyroid are differentiated cancers that look like normal thyroid tissue, even under the microscope, and affect the hormone-producing cells processing iodine. American Cancer Society says more than 62,000 people in the U.S. will develop thyroid cancer this year — with 3 times more women than men getting the disease — resulting in nearly 2,000 deaths.

Lenvima limits the ability of enzymes supporting receptors for proteins that promote development of blood vessels and other cells feeding the growth of thyroid tumors. FDA granted the drug priority review, a program that expedites evaluation of new drugs that show significant improvements in safety or effectiveness. The agency says it completed that review 2 months ahead of schedule.

FDA based its approval in part on results of a late-stage clinical trial of nearly 400 patients with progressive thyroid cancer, despite having earlier received radioactive iodine therapy. Results of the trial appeared last week in New England Journal of Medicine (paid subscription required).

Participants in the trial were randomly assigned 2-to-1 to receive Lenvima or a placebo, taken once a day in 24 milligram doses for 28 days. The study looked primarily at overall survival time of patients, but also effect of the drug on their tumors, as well as safety of the drug.

The findings clearly support the drug’s effectiveness. Patients receiving Lenvima survived for more than 18 months, while those receiving the placebo survived for about 4 months. In addition, about two-thirds (65%) of patients receiving Lenvima experienced a reduction in tumor size, compared to about 2 percent of those receiving the placebo.

But many patients receiving the drug had adverse reactions to it. In the trial, 40 percent or more of patients receiving Lenvima experienced high blood pressure, diarrhea,  fatigue, nausea, and decreased weight and appetite. Of the 261 patients receiving Lenvima, 37 or 14 percent had to discontinue to drug because of adverse reactions, compared to 2 percent receiving the placebo. Also, 6 of 20 deaths of patients receiving Lenvima during the trial were considered to be related to the drug.

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