Exelixis has completed the submission of new drug application (NDA) for cabozantinib as a treatment for progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC) patients, with the FDA.
Cabozantinib is a potent targeted therapy that inhibits MET, VEGFR2 and RET.
As a part of the NDA filing, which is based on data from a Phase III pivotal trial in patients with advanced MTC, Exelixis has requested Priority Review designation from the FDA.
The EXAM trial with progression-free survival (PFS) as the primary endpoint was conducted under a Special Protocol Assessment with the FDA.
In October 2011, the company announced top-line results from the trial that met its primary endpoint of improving PFS: compared with placebo, cabozantinib improved median PFS by 7.2 months.
