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FDA Approves Cabozantinib for Previously Treated Hepatocellular Carcinoma

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On January 14, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) tablets for patients with hepatocellular carcinoma who have been previously treated with sorafenib.

The FDA’s approval of cabozantinib was based on results from the phase III CELESTIAL trial.

“Patients with this form of advanced liver cancer have few treatment options, particularly once their disease progresses following treatment with sorafenib,” said Ghassan K. Abou-Alfa, MD, of Memorial Sloan Kettering Cancer Center and lead investigator of the CELESTIAL trial. “Physicians are eager for new options for these patients, and the results of the CELESTIAL trial demonstrate that cabozantinib has the efficacy and safety profile to become an important new therapy in our efforts to slow disease progression and improve treatment outcomes.”

Cabozantinib is an oral tyrosine kinase inhibitor.

More About CELESTIAL

Data from the CELESTIAL trial were originally presented at the 2018 Gastrointestinal Cancers Symposium (Abstract 207) and were published in The New England Journal of Medicine in July 2018.

In the trial, median overall survival was 10.2 months with cabozantinib vs 8.0 months with placebo (hazard ratio [HR] = 0.76, 95% confidence interval [CI] 0.63–0.92; P = .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 < .0001). Objective response rates per RECIST 1.1 were 4% with cabozantinib and 0.4% with placebo (P = .0086). Disease control (partial response or stable disease) was achieved by 64% of patients in the cabozantinib group compared with 33% of patients in the placebo group.

Adverse events in CELESTIAL were consistent with the known safety profile of cabozantinib. The most common (≥ 10%) grade 3 or 4 adverse events in the cabozantinib group compared to the placebo group were palmar-plantar erythrodysesthesia (17% vs 0%), hypertension (16% vs 2%), increased aspartate aminotransferase (12% vs 7%), fatigue (10% vs 4%), and diarrhea (10% vs 2%). Treatment-related grade 5 adverse events occurred in six patients in the cabozantinib group (hepatic failure, esophagobronchial fistula, portal vein thrombosis, upper gastrointestinal hemorrhage, pulmonary embolism, and hepatorenal syndrome) and in one patient in the placebo group (hepatic failure). Sixteen percent of patients in the cabozantinib arm and 3% of patients in the placebo arm discontinued treatment due to treatment-related adverse events.

View the full prescribing information for cabozantinib here.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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