Exelixis, Inc. (NASDAQ:EXEL) today announced that its partner Ipsen Biopharmaceuticals Canada Inc. received Health Canada approval of CABOMETYX® (cabozantinib) tablets for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
“Liver cancer is the fourth leading cause of cancer-related death globally, and there is an urgent need for more treatment options for patients living with this aggressive disease,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “The Health Canada approval of CABOMETYX brings a much-needed new therapy to Canadian patients with liver cancer and we look forward to our continued collaboration with Ipsen in our efforts to make our medicines available to patients around the world.”
The Health Canada approval was based on results from the CELESTIAL phase 3 pivotal trial of CABOMETYX for patients with advanced HCC who received prior treatment with sorafenib. CABOMETYX demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo.
Under the terms of the Collaboration Agreement with Ipsen, Exelixis will receive a milestone payment of $2 million for the Health Canada approval.
CABOMETYX 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.