Cabometyx Receives New Indication
January 16, 2019 – The U.S. FDA has approved Cabometyx® (cabozantinib) tablets, manufactured by Exelixis, to treat patients who have hepatocellular carcinoma (HCC) and have previously been treated with Bayer’s Nexavar® (sorafenib).
HCC is the most common form of liver cancer in the United States and the sixth most prevalent form of cancer worldwide. It is also one of the fastest rising causes of cancer-related death in the U.S. In the majority of cases, patients have a history of liver cirrhosis (late-stage scarring) caused by chronic infection with hepatitis B or C.
In clinical studies, patients who received Cabometyx had an overall survival time of 10.2 months versus 8.0 months with placebo. The median progression free survival time was 5.2 months with Cabometyx and 1.9 months with placebo. Disease control, defined as a partial response or stable disease, was achieved by 64% of patients who received Cabometyx, versus 33% of patients who received the placebo. Recommended dosing is 60mg taken once daily, at least one hour before or two hours after eating.
Cabometyx tablets first received FDA approval in 2012. In addition to the new HCC indication, they are approved to treat advanced renal cell carcinoma (RCC). The active ingredient in Cabometyx tablets is also available in a capsule form, marketed under the brand name Cometriq® (cabozantinib) and manufactured by Exelixis. However, the two products have different FDA-approved indications and are not interchangeable.