You are here

FDA Approves Cabometyx for Patients With Aggressive Liver Cancer

New Therapy for Patients With HCC Who Previously Received Nexavar

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

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs
Acasti reports disappointing results for a second Omega-3-based drug
Declining lung cancer mortality helped fuel the progress