Bayer reports that it has submitted an application for approval of its cancer drug Stivarga (regorafenib) to expand its use to the second-line treatment of liver cancer patients.
The application to authorities in the U.S., Japan and Europe to extend the marketing authorisation of the oral multi-kinase inhibitor follows successful clinical trials. Regorafenib has previously been approved in a number of countries for the treatment of colorectal cancer and gastrointestinal stromal tumours.
The drug acts by blocking multiple protein kinases involved in tumour angiogenesis. The German drugmaker now seeks approval for regorafenib to treat unresectable hepatocellular carcinoma (HCC) after first-line treatment.
The application is based on data from the Phase III RESORCE study, conducted earlier this year, which showed that the drug helped to extend the lives of liver cancer patients. The study investigated the effect of regorafenib in patients with unresectable HCC whose disease had progressed during treatment with Nexavar (sorafenib).
Approximately 780,000 people are diagnosed with the disease worldwide each year.
Dr Jordi Bruix, BCLC Group, Liver Unit, Hospital Clinic, University of Barcelona, and principal investigator of the RESORCE and SHARP trials, said: “Regorafenib is the first treatment to successfully deliver an overall survival benefit in the second-line setting for HCC and has the potential to change the treatment paradigm by becoming the new standard of care for patients who progress on sorafenib.”