Posted by Michael Wonder on 16 Mar 2018
Exelixis submits U.S. supplemental new drug application for Cabometyx (cabozantinib) for previously treated advanced hepatocellular carcinoma
15 March 2018 - In the pivotal phase 3 CELESTIAL trial, Cabometyx provided a statistically significant and clinically meaningful improvement versus placebo in overall survival.
Exelixis today announced it has completed the submission of a supplemental new drug application to the U.S. FDA for Cabometyx (cabozantinib) tablets as a treatment for patients with previously treated advanced hepatocellular carcinoma (HCC). The submission is based on results from the CELESTIAL randomised pivotal phase 3 trial of Cabometyx in patients with advanced HCC who received prior sorafenib.
On 16 October 2017, Exelixis announced that the independent data monitoring committee for the study recommended that the CELESTIAL trial be stopped for efficacy following review at the second planned interim analysis, with cabozantinib providing a statistically significant and clinically meaningful improvement in overall survival compared with placebo in patients with previously treated advanced HCC (pre-specified critical p-value ≤ 0.021). In March 2017, the FDA granted orphan drug designation to cabozantinib for the treatment of advanced HCC.
