Additional Relevant Details
Takeda’s application is based on the results of two clinical trials in patients with advanced HCC who had received prior systemic therapy: CELESTIAL (XL184-309), a global, randomized, placebo-controlled, double-blind phase 3 clinical trial, and Cabozantinib-2003, a phase 2 clinical trial conducted in Japan. The CELESTIAL trial was the basis for the CABOMETYX approvals in the U.S. and the EU for the treatment of patients with HCC who have been previously treated with sorafenib.