The US Food and Drug Administration (FDA) has approved Cometriq, the lead product of biotechnology company Exelixis, for the treatment of progressive, metastatic medullary thyroid cancer (MTC).
The approval of Cometriq, an inhibitor of multiple receptor tyrosine kinases involved in both normal cellular function and pathologic processes, is based on the results of EXAM, a randomised Phase III clinical trial.
EXAM enrolled 330 patients with progressive, metastatic MTC and met its primary efficacy endpoint of improving progression-free survival.
Exelixis completed its rolling New Drug Application in May 2012, with the FDA providing priority status to the filing.
Exelixis president and CEO Dr Michael M Morrissey said the approval of Cometriq is an important milestone for patients with progressive, metastatic MTC and their families, as well the company.
"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," said Morrisey.
MD Anderson Cancer Center Naguib Samaan distinguished professor in endocrinology Dr Steven I Sherman said the availability of a new therapeutic approach will change the MTC treatment landscape.
"There has been little clinical progress in treating advanced MTC until the introduction of targeted therapies, and it is gratifying to give these patients a new treatment option that has been shown in clinical trials to improve progression-free survival remarkably by nearly three-fold," Sherman said.