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FDA Approves Cometriq (Cabozantinib) for Metastatic Thyroid Cancer

Kinase inhibitor blocks abnormal proteins involved in cancer cell growth (Nov. 29)

The FDA announced on November 29 that it has approved Cometriq (cabozantinib, Exelixis) to treat metastatic medullary thyroid cancer.

Medullary thyroid cancer develops in cells in the thyroid gland that produce the hormone calcitonin, which helps maintain a healthy level of calcium in the blood. This type of cancer may occur spontaneously or in families with certain genetic mutations that result in one or more cancers of the endocrine system, including the thyroid gland.

The National Cancer Institute estimates that 56,460 Americans will be diagnosed with thyroid cancer and 1,780 will die from the disease in 2012. About 4% of thyroid cancers are medullary thyroid cancer, making it one of the rarer types of thyroid cancers.

Cometriq is the second drug to receive FDA approval for the treatment of medullary thyroid cancer within the past 2 years. Caprelsa (vandetanib, AstraZeneca) was approved in April 2011.

Cometriq (cabozantinib) is a kinase inhibitor that blocks abnormal kinase proteins involved in the development and growth of medullary cancer cells.

The safety and effectiveness of Cometriq were established in a clinical study involving 330 patients with medullary thyroid cancer. Treatment with Cometriq increased progression-free survival and, in some patients, reduced the size of tumors (response rate).

Patients who were given Cometriq lived an average of 11.2 months without tumor growth compared with an average of 4.0 months in patients receiving placebo. Study results also showed that 27% of patients treated with Cometriq had reductions in tumor size lasting an average of almost 15 months, while patients who received placebo experienced no reductions. Treatment with Cometriq did not extend patients’ lives.

The prescribing information for Cometriq includes a boxed warning alerting patients and healthcare professionals that severe and fatal bleeding as well as perforations and fistulae in the colon have occurred in some patients.

The most common side effects of treatment with Cometriq were diarrhea; inflammation or sores of the mouth; redness, pain, or swelling of the digits (hand-foot syndrome); weight loss; loss of appetite; nausea; fatigue; oral pain; graying or loss of hair color; bad taste; new or worsening high blood pressure; abdominal pain; and constipation.

Source: FDA; November 29, 2012.

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