Cabozantinib Approved to Treat Rare Type of Thyroid Cancer ► NCI Cancer Bulletin for December 11, 2012 - National Cancer Institute

NCI Cancer Bulletin for December 11, 2012 - National Cancer Institute

Cabozantinib Approved to Treat Rare Type of Thyroid Cancer

The Food and Drug Administration (FDA) approved cabozantinib (Cometriq) to treat medullary thyroid cancer that has spread to other parts of the body.
Medullary thyroid cancer is a rare type of thyroid cancer. The disease develops in cells in the thyroid gland that make a hormone called calcitonin, which helps maintain a healthy level of calcium in the blood. Cabozantinib is a kinase inhibitor that blocks abnormal kinase proteins involved in the development and growth of medullary cancer cells.
“Prior to today’s approval and the approval of [vandetanib] in April 2011, patients with this rare and difficult-to-treat disease had limited therapeutic treatment options,” Dr. Richard Pazdur, director of FDA’s Office of Hematology and Oncology Products, said in a news release.
The safety and effectiveness of cabozantinib were established in a clinical study that included 330 patients with medullary thyroid cancer. Patients treated with cabozantinib lived longer without the cancer progressing, and some experienced tumor shrinkage.
Patients who were given cabozantinib lived a median of 11.2 months without tumor growth compared with a median of 4 months for patients receiving a placebo. In 27 percent of patients treated with cabozantinib, tumors shrank, with the response lasting for a median of nearly 15 months, whereas none of the tumors shrank in patients who received a placebo. Treatment with cabozantinib did not extend patients’ lives.
The drug was approved with a boxed warning alerting patients and health care professionals that severe and fatal bleeding and perforations and fistulas in the colon occurred in some patients.
The most common side effects included diarrhea, inflammation or sores of the mouth, hand-foot syndrome, nausea, fatigue, new or worsening high blood pressure, and abdominal pain and constipation. The most common laboratory abnormalities included increases in liver enzymes, low calcium and phosphorus levels, and decreased white blood cells and platelets.