15 January 2019 - - The US Food and Drug Administration approved Carbometyx (cabozantinib) tablets for patients with hepatocellular carcinoma who have been previously treated with sorafenib, US-based Exelixis, Inc. (NASDAQ: EXEL) said.

HCC is the most common form of liver cancer and the fastest-rising cause of cancer-related death in the US1

The FDA's approval of Carbometyx was based on results from the CELESTIAL phase 3 pivotal trial of Carbometyx for patients with advanced HCC who received prior sorafenib. Carbometyx demonstrated a statistically significant and clinically meaningful improvement in overall survival versus placebo.

On November 15, 2018, Exelixis' partner Ipsen received approval from the European Commission for Carbometyx 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% 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% CI 0.36-0.52; p