Exelixis was granted FDA approval for cabozantonib (Cabometyx) for patients with hepatocellular carcinoma (HCC) who have previously received Nexavar (sorafenib, Bayer).
Cabozantonib’s new indication represents an important treatment advance for patients with HCC, an aggressive liver cancer. There are limited treatment options available, particularly once the disease has progressed with sorafenib treatment.
The FDA granted approval based on results from a phase 3 clinical trial of cabozantinib versus placebo for patients with HCC who had previously received sorafenib.
Patients administered cabozantinib had significantly improved rates of overall survival and progression-free survival compared with patients receiving placebo. Also, patients treated with cabozantinib were more likely to achieve partial response or stable disease versus those receiving placebo.
The most common serious adverse events included palmar-plantar erythrodysesthesia, hypertension, increased aspartate aminotransferase, fatigue, and diarrhea. Among the treatment-related grade 5 adverse events, which occurred in six patients, were hepatic failure, esophagobronchial fistula, portal vein thrombosis, upper gastrointestinal hemorrhage, pulmonary embolism, and hepatorenal syndrome.
Cabozantinib was previously approved for patients with advanced renal cell carcinoma.
Source: Healio.com, January 15, 2019