Exelixis, Inc. (NASDAQ: EXEL) today announced that the U.S. Food and Drug Administration (FDA) has approved COMETRIQ™ (cabozantinib) for the treatment of progressive, metastatic medullary thyroid cancer (MTC). COMETRIQ is an inhibitor of multiple receptor tyrosine kinases involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and maintenance of the tumor microenvironment. The COMETRIQ label has boxed warnings concerning risk of perforations and fistulas, and hemorrhage.
Exelixis completed its rolling New Drug Application (NDA) in May 2012, and the FDA granted Priority Review Designation to the filing, assigning a Prescription Drug User Fee Act (PDUFA) action date of November 29, 2012. The COMETRIQ approval is based on the results of EXAM, a randomized phase 3 clinical trial conducted in 330 patients with progressive, metastatic MTC, which met its primary efficacy endpoint of improving progression-free survival (PFS).
"The approval of COMETRIQ is an important milestone for patients with progressive, metastatic medullary thyroid cancer, their families, and their physicians, as well as for Exelixis," said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. "We are grateful to the many patients who participated in the clinical development of COMETRIQ in MTC, and we are committed to making this important new therapy available as quickly as possible."