Exelixis announced that the FDA has approved Cometriq (cabozantinib) capsules for the treatment of progressive, metastatic medullary thyroid cancer (MTC).
The approval is based on the results of EXAM, a randomized Phase 3 clinical trial conducted in 330 patients with progressive, metastatic MTC. Patients were randomized (2:1) to receive Cometriq 140mg (n=219) or placebo (n=111) orally, once daily until disease progression determined by the treating physician or until intolerable toxicity. A statistically significant prolongation in progression-free survival (PFS) was demonstrated among Cometriq-treated patients compared to those receiving placebo [HR 0.28 (95% CI: 0.19, 0.40); P<0.0001], with median PFS times of 11.2 months and 4.0 months in the Cometriq and placebo arms, respectively.
Cometriq is an inhibitor of multiple receptor tyrosine kinases (including RET, MET, VEGFR2) involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and maintenance of the tumor microenvironment.
Cometriq will be available in 20mg and 80mg strength capsules in 140mg, 100mg, and 60mg daily-dose cartons, as well as 60-count bottles of the 20mg capsules.
For more information call (650) 837-7000 or visit www.COMETRIQ.com.