Bayer announced that the U.S. Food and Drug Administration (FDA) approved Stivarga® (regorafenib) tablets for the second-line treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar® (sorafenib). Stivarga is the first and only treatment to demonstrate significant improvement in overall survival in second-line HCC patients. In the RESORCE trial, Stivarga was shown to provide a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo. Today’s FDA approval expands Bayer’s leadership in liver cancer with a treatment plan in HCC involving use of Stivarga directly after progression on Nexavar.
Stivarga is an oral inhibitor of multiple kinases involved in normal cellular functioning and in pathological processes such as oncogenesis, tumor angiogenesis, metastasis and tumor immunity. The FDA’s approval is based on data from the international, multicenter, placebo-controlled Phase III.
“Bayer is proud to have played a significant role in the treatment of hepatocellular carcinoma,” said Robert LaCaze, executive vice president and head of the Oncology Strategic Business Unit at Bayer. “We first embarked on our scientific research in this area 20 years ago and we have remained steadfast in our mission to deliver new treatment options to these patients. We could not have done it alone: we would like to thank the patients, caregivers and investigators for their participation and engagement in the study.”
Thomas F. Nealon III, national board chair and chief executive officer of the American Liver Foundation, commented, “Given that the incidence of liver cancer continues to rise, we applaud the efforts of Bayer and the RESORCE study investigators for ushering in this much-needed treatment option for patients with liver cancer.”
The approval of Stivarga 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 Stivarga in this indication, which is an expedited program designed to facilitate development and review of drugs to address unmet medical need in the treatment of a serious or life-threatening condition. The FDA also granted Orphan Drug Designation (ODD) to Stivarga in HCC. The ODD program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders.
Additional regulatory filings for Stivarga in HCC are under review in countries around the world, including the EU, Japan and China. Decisions in the EU and Japan are expected later in this year.