FDA OKs Cabozantinib for Previously-Treated Hepatocellular Carcinoma


Cabozantinib’s new indication provides an additional therapeutic option for patients with advanced liver cancer who have been previously treated with sorafenib.

Officials with the FDA have approved cabozantinib (Cabometyx, Exelixis) tablets for patients with previously-treated hepatocellular carcinoma (HCC), according to a press release.

Cabozantinib has been previously approved for the treatment of patients with advanced renal cell carcinoma. With its expanded approval, cabozantinib will be available for patients with HCC, the most common form of liver cancer, who were previously treated with sorafenib.

The FDA’s approval of the new indication is based on data from the CELESTIAL phase 3 study of cabozantinib, which showed statistically significant and clinically meaningful benefits. The trial enrolled 760 patients with advanced HCC who received prior sorafenib and may have received up to 2 prior systemic cancer therapies for HCC and had adequate liver function. For the study, patients received either 60 mg of cabozantinib once daily or a placebo.

According to the data, median overall survival was 10.2 months with cabozantinib versus 8 months with a placebo (HR 0.76, 95% CI 0.63-0.92; p=0.0049). The study also showed patients treated with cabozantinib had a median progression-free survival (PFS) of 5.2 months compared with 1.9 months with a placebo (HR 0.44, 95% CI 0.36-0.52; p<0.0001). Additionally, 64% of patients treated with cabozantinib achieved disease control compared with 33% in the placebo group.

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

Adverse events (AEs) reported in the CELESTIAL trial were consistent with the known safety profile of cabozantinib, with the most common AEs being palmar-plantar erythrodysesthesia, hypertension, increased aspartate aminotransferase, fatigue, and diarrhea.

The phase 3 COSMIC-312 trial, which was initiated in December 2018, is evaluating cabozantinib in combination with atezolizumab versus sorafenib in previously untreated advanced HCC, according to Exelixis.


Exelixis Annonces US FDA Approval of CABOMETYX (cabozantinib) Tablets for Previously Treated Hepatocellular Carcinoma [news release]. Exelixis’ website. http://ir.exelixis.com/phoenix.zhtml?c=120923&p=irol-newsArticle&ID=2383313. Accessed January 15, 2018.

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