publication date: Jan. 18, 2019

Drugs & Targets

FDA approves Cabometyx for previously treated hepatocellular carcinoma

FDA approved Cabometyx (cabozantinib) tablets for patients with hepatocellular carcinoma who have been previously treated with sorafenib.

Cabometryx is sponsored by Exelixis.

The approval was based on results from the CELESTIAL phase III pivotal trial of Cabometyx for patients with advanced HCC who received prior sorafenib.

Cabometyx demonstrated a statistically significant and clinically meaningful improvement in overall survival versus placebo. In November 2018, Exelixis’ partner Ipsen received approval from the European Commission for CABOMETYX tablets as a monotherapy for HCC in adults who have previously been treated with sorafenib.

In the pivotal CELESTIAL trial, median OS was 10.2 months with cabozantinib versus 8.0 months with placebo (HR 0.76, 95 percent CI 0.63-0.92; p=0.0049). Median progression-free survival was more than doubled, at 5.2 months with cabozantinib and 1.9 months with placebo (HR 0.44, 95 percent CI 0.36-0.52; p<0.0001).

Objective response rates per RECIST 1.1 were 4 percent with cabozantinib and 0.4 percent with placebo (p=0.0086). Disease control (partial response or stable disease) was achieved by 64 percent of patients in the cabozantinib group compared with 33 percent of patients in the placebo group.

In December 2018, Exelixis and its partner Ipsen announced the initiation of COSMIC-312, a phase III pivotal trial of cabozantinib in combination with atezolizumab versus sorafenib in previously untreated advanced HCC. The trial will also explore single-agent activity of cabozantinib in the first-line setting. For more information about the trial, visit

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 … Continue reading FDA approves Cabometyx for previously treated hepatocellular carcinoma

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