Rare thyroid cancer drug approved by US FDA

Hannah Blake

pharmaphorum

The FDA has approved Exelixis Inc's Cometriq to treat patients in the United States who have medullary thyroid cancer that has spread to other parts of the body. The drug has also received orphan-product designation by the FDA, because it is intended to treat a rare disease or condition.

The FDA completed the review of Cometriq (cabozantinib) in six months under the agency’s priority review program. The drug’s approval was based on a clinical study involving 330 patients with medullary thyroid cancer. Patients who were given Cometriq lived an average of 11.2 months without tumour growth, compared to an average of four months in patients on placebo. Results are showed that 27% of patients treated with Cometriq had reductions in tumour size lasting an average of nearly 15 months, while patients on placebo saw no reductions. Treatment with Cometriq did not extend patients’ lives.

“Cometriq is the second drug approved to treat medullary thyroid cancer in the past two years and reflects FDA’s commitment to the development and approval of drugs for treating rare diseases. Prior to today’s approval and the approval of Caprelsa in April 2011, patients with this rare and difficult to treat disease had limited therapeutic treatment options.”

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

According to the National Cancer Institute, approximately 56,460 Americans will be diagnosed with thyroid cancer in 2012. Around 4% of thyroid cancers are medullary thyroid cancer, making it one of the rarer types of thyroid cancers.

&nbsp,