Cometriq Approved for Rare Thyroid Cancer
THURSDAY, Nov. 29 -- Cometriq (cabozantinib) has been approved by the U.S. Food and Drug Administration to treat modullary thyroid cancer that has spread to other parts of the body, the agency said Thursday.
The modullary form accounts for about 4 percent of the more than 56,000 cases of thyroid cancer diagnosed annually in the United States, the FDA said in a news release. This type of cancer develops in thyroid cells that produce a hormone that helps regulate blood calcium.
Cometriq is a kinase inhibitor that's designed to block the effects of proteins involved in cancer cell development and growth. People should not eat at least two hours before, and one hour after, taking the drug, the agency said.
Cometriq's safety and effectiveness was evaluated in clinical studies involving 330 people with modullary thyroid cancer. Those given Cometriq lived an average of 11.2 months without tumor growth, compared with an average of four months among people who took a placebo. The drug "did not extend patients' lives," the FDA said.
The product's label has a boxed warning of the potential for severe and fatal bleeding of the colon, the FDA said.
More common and less serious side effects may include diarrhea, mouth sores, redness and swelling of the fingers or toes, weight loss, appetite suppression and nausea.
Cometriq is marketed by Exelixis, based in San Francisco.
The U.S. National Library of Medicine has more about modullary thyroid cancer.
Posted: November 2012