Bayer is pleased to announce that the Scottish Medicines Consortium (SMC) has accepted for use Stivarga®▼(regorafenib) as a monotherapy for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar® (sorafenib).
Regorafenib is the first medicine to be specifically licensed for second-line use in patients with hepatocellular cancer (HCC) who have been previously treated with sorafenib. It is taken orally and works by slowing down the growth and spread of cancer cells by cutting off the blood supply that keeps cancer cells growing.
The positive SMC announcement follows the recent decision from the National Institute for Health and Care Excellence (NICE) to not recommend the use of regorafenib on the NHS in England. SMC gives positive decision for Stivarga®▼ (regorafenib) for treatment of adults with hepatocellular carcinoma who have been previously treated with sorafenib
Regorafenib is licensed based on data from the international, multicentre, placebocontrolled Phase III RESORCE trial, which investigated patients with HCC whose disease had progressed during treatment with sorafenib. In the trial, regorafenib plus best supportive care (BSC) was shown to provide a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo plus BSC which translates to a 37% reduction in the risk of death over the trial period.
Judi Rhys, Chief Executive of the British Liver Trust said, “A diagnosis of hepatocellular carcinoma (HCC) is truly devastating – it is a horrendous type of liver cancer that is often diagnosed very late with few treatment options. Evidence shows that outcomes for people with advanced liver cancer are particularly poor, so this is an important step.”