The U.S. Food and Drug Administration (FDA) has approved the expanded use of Bayer HealthCare Pharmaceuticals’ Stivarga (regorafenib) to treat hepatocellular carcinoma (HCC, the most common form of liver cancer), Medscape reports.
Stivarga was already approved to treat colorectal cancer and gastrointestinal stromal tumors that have stopped responding to previous treatments. The drug is a kinase inhibitor, working by blocking various enzymes that contribute to cancer growth.
The new FDA approval was based on a randomized trial of 573 people with liver cancer whose tumors had advanced following treatment with Nexavar (sorafenib).
The respective median overall survival time among those receiving Stivarga and a placebo was 10.6 months and 7.8 months.
The respective periods of survival during which their liver cancer did not progress were 3.1 months and 1.5 months among those receiving Stivarga versus the placebo. A respective 10.6 percent and 4.1 percent experienced a complete or partial response to treatment.
A respective 79.7 percent and 58.5 percent of those receiving Stivarga and the placebo experienced adverse health events of grade 3 or higher. The most common were high blood pressure (15.2 percent versus 4.7 percent), skin reactions on the hands and feet (12.8 percent versus 0.5 percent), fatigue (9.1 percent versus 4.7 percent) and diarrhea (3.2 percent versus zero).
To read an FDA press release, click here.
To read the Medscape article, click here (free registration with the site is required).