Cabozantinib Granted FDA Approval for Advanced HCC – APhA submits compounding comments to FDA. – (866) 348-2889.
The FDA has approved cabozantinib (Cabometyx, Exelixis) as a treatment for patients with hepatocellular carcinoma (HCC) who previously received sorafenib (Nexavar, Bayer), according to Exelixis, the company developing the therapy.
The approval was based on findings from the phase III CELESTIAL trial, in which overall survival (OS) was improved by 2.2 months with cabozantinib versus placebo. Median OS with cabozantinib was 10.2 versus 8.0 months for placebo, representing a 24% reduction in the risk of death (HR, 0.76; 95% CI, 0.63-0.92; P = .0049).
Results from the CELESTIAL trial were first presented at the 2018 Gastrointestinal Cancers Symposium. The study was stopped in October 2017, following a positive interim analysis that showed a significant improvement in OS for cabozantinib. The stoppage was preplanned if the P value for OS reached ≤.021.