FDA Approves COMETRIQ (Cabozantinib) To Treat Medullary Thyroid Cancer
The U.S. Food and Drug Administration today approved Cometriq (cabozantinib) to treat progressive, metastatic medullary thyroid cancer. Cometriq 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. 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).
Exelixis expects to have Cometriq available by late January. In the meantime, patients can enroll in the company’s Expanded Access Program (EAP). Information on the EAP can be obtained by calling (855) 253-3273 or going to Exelixis’s Cometriq website.
Exelixis plans to provide comprehensive access and reimbursement services through a program called Exelixis Access Services. Details can be obtained by calling 855-253-3273 or visiting the Cometriq website at www.cometriq.com. The website also has full prescribing information for Cometriq.
Cometriq is the second drug approved to treat progressive, metastatic medullary thyroid cancer in the past 2 years (the other drug is Caprelsa from AstraZeneca). Medullary thyroid cancer is rare, diagnosed in about 4 percent of the 56,460 people who will be diagnosed with thyroid cancer in the United States during 2012.
For more information about MTC and all types of thyroid cancer, free on-demand Webinars with experts, ThyCa’s 12 Online Support Groups for each type and situation with thyroid cancer, local support groups, free publications, and more, visit the web site of ThyCa: Thyroid Cancer Survivors’ Association, Inc.