Exelixis will be celebrating news that US regulators have issued a green light for its medullary thyroid cancer drug Cometriq (cabozantinib).
Specifically, the US Food and Drug Administration has cleared the use of the drug to treat patients with progressive, metastatic forms of the disease.
Cometriq works by inhibiting of multiple receptor tyrosine kinases that play a role in both normal cellular function and pathologic processes, including oncogenesis and tumour angiogenesis.
Approval of the drug, which was granted a priority review in the US earlier this year, follows positive data from the Phase III EXAM trial, which met its primary efficacy endpoint of improving progression-free survival.
According to results of this study, median PFS times were 11.2 months and 4.0 months in the Cometriq and placebo arms, respectively, clearly indicating its potential benefit.
"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,” noted senior study investigator Professor Steven I. Sherman.
Cometriq has, however, been slapped with a boxed warning regarding the risk of perforations and fistulas, and haemorrhage.
Meanwhile, Exelixis also announced that across the Atlantic the European Medicines Agency has accepted its marketing application for the drug.
The filing is also based on data from the EXAM trial.