Cabozantinib for HCC in CanadaJanuary 6, 2020
Health Canada has granted approval for cabozantinib (Cabometyx) tablets for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
The approval was based on results from the CELESTIAL phase 3 pivotal trial of cabozantinib for patients with advanced HCC who received prior treatment with sorafenib. The drug demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo.
Cabozantinib is also approved in Canada for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior vascular endothelial growth factor targeted therapy and for the first-line treatment of adults with intermediate or poor-risk advanced RCC.
CELESTIAL is a randomized, double-blind, placebo-controlled study of cabozantinib in patients with advanced HCC conducted at more than 100 sites globally in 19 countries. The trial was designed to enroll 760 patients with advanced HCC who received prior treatment with sorafenib and may have received up to two prior systemic cancer therapies for HCC and had adequate liver function.