This article is more than 5 years old. Information may no longer be current.

FDA approves cabozantinib for patients with medullary thyroid cancer

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

The FDA today approved cabozantinib to treat patients with metastatic medullary thyroid cancer.

Cabozantinib (Cometriq, Exelixis) also received orphan-product designation by the FDA because it is intended to treat a rare disease or condition, according to an FDA press release.

The FDA completed review of the oral thyroid drug in 6 months under the agency’s priority review program. The priority program expedites the FDA review for drugs that could offer major advances in treatment or provide a treatment when no sufficient treatment exists.

“Cometriq is the second drug approved to treat medullary thyroid cancer in the past 2 years and reflects FDA’s commitment to the development and approval of drugs for treating rare diseases,” Richard Pazdur, MD, director of the Office of Hematology and Oncology in the Center for Drug Evaluation and Research at the FDA said in a press release. “Prior to today’s approval and the approval of Caprelsa (AstraZeneca, vandetanib) in April 2011, patients with this rare and difficult to treat disease had limited therapeutic treatment options.”

The approval comes after the safety and effectiveness of the drug was established in a clinical study involving 330 patients with medullary thyroid cancer. Treatment with cabozantinib increased PFS and reduced the size of tumors in some patients as well.

Patients treated with cabozantinib lived an average of 11.2 months without tumor growth compared to an average of 4 months in patients receiving a placebo. Data from the study also indicated 27% of patients treated with cabozantinib had a reduction in tumor size lasting nearly 15 months. Patients treated with a placebo saw no reductions. Cabozantinib did not improve patient OS.

The most common side effects for the drug included diarrhea; inflammation or soles of the mouth; redness, pain, or swelling of the digits; 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.