Bayer has gained US FDA approved for Stivarga tablets for the second-line treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar.
Regorafenib is the first and only treatment to demonstrate significant improvement in overall survival in second-line HCC patients.
Regorafenib is an oral inhibitor of multiple kinases involved in normal cellular functioning and in pathological processes such as oncogenesis, tumour angiogenesis, metastasis and tumour immunity.
The FDAs approval is based on data from the international, multicenter, placebo-controlled Phase III Resorce trial, which investigated patients with HCC whose disease had progressed during treatment with sorafenib.
Hepatocellular carcinoma is very hard to treat, and with no new licensed treatments in nearly a decade, options have been very limited for physicians and patients, said Dr Jordi Bruix, lead investigator for the Resorce trial, BCLC Group, Liver Unit, Hospital Clinic, University of Barcelona.
The approval of regorafenib for hepatocellular carcinoma therefore provides a significant step forward in addressing the high unmet need in this patient population.
The incidence of liver cancer is increasing worldwide and it is already the sixth most common cancer in the world and the second leading cause of cancer-related deaths globally.
The approval of regorafenib in liver cancer marks the third time that this therapy has been granted FDA approval on a priority basis.
The FDA granted Fast Track designation to regorafenib in HCC, which is an expedited program designed to facilitate development and review of drugs to address an unmet medical need in the treatment of a serious or life-threatening condition.
Additional regulatory filings for regorafenib in HCC are under review in countries around the world, including the European Union, Japan and China.
Decisions in the EU and Japan regions are expected later this year.