United States-based Exelixis has received approval from the United States Food and Drug Administration (FDA) for its CABOMETYX (cabozantinib) tablets intended for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib, it was reported yesterday.

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

Michael M Morrissey, PhD, president and chief executive officer of Exelixis, said, 'This new indication for CABOMETYX is an important treatment advance for patients with this aggressive form of liver cancer, a community in need of new therapeutic options. This approval is an important milestone as we continue to explore how CABOMETYX may benefit people with difficult-to-treat-cancers beyond renal cell carcinoma. We would like to thank the patients and clinicians who participated in CELESTIAL and to acknowledge the team at the FDA for their continued collaboration during the review of our application.'