FDA Approves Cometriq to Treat Rare Type of Thyroid Cancer
The FDA completed review of Cometriq’s application in six months under the agency’s priority review program. This program provides for an expedited six-month review for drugs that may offer major advances in treatment or that provide a treatment when no adequate therapy exists. Cometriq also received orphan-product designation by the FDA because it is intended to treat a rare disease or condition.
Cometriq is a kinase inhibitor that blocks abnormal kinase proteins involved in the development and growth of medullary cancer cells. Patients should not eat for at least two hours before and onw hour after taking Cometriq.
Patients who were given Cometriq lived an average of 11.2 months without tumor growth compared with an average of four months in patients receiving a sugar pill (placebo).
The safety and effectiveness of Cometriq were established in a clinical study involving 330 patients with medullary thyroid cancer. Treatment with Cometriq increased the length of time a patient lived without the cancer progressing (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 four months in patients receiving a sugar pill (placebo). Results also showed that 27 percent of patients treated with Cometriq had reductions in tumor size lasting an average of nearly 15 months, while patients who received a placebo saw no reductions. Treatment with Cometriq did not extend patients’ lives.
The prescribing information for Cometriq includes a Boxed Warning alerting patients and health care professionals that severe and fatal bleeding and holes (perforations and fistula) in the colon occurred in some patients.
The most common side effects 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. The most common laboratory abnormalities included increases in liver enzymes, low calcium and phosphorus, decreased white blood cells and platelets.
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Cometriq is marketed by Exelixis, based in South San Francisco, Calif. Caprelsa (vandetanib) is marketed by Wilmington, Del.-based AstraZeneca Pharmaceuticals. For more information, visit cometriq.com.