A global enterprise with core competencies in the Life Science fields, Bayer is committed to developing innovative treatments for cancer. In April 2017, the U.S. Food and Drug Administration (FDA expanded the approved use of Bayer's Stivarga (regorafinib) to include the second-line treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar (sorafenib). This is the first FDA-approved treatment for liver cancer in almost a decade.
Liver cancer is an increasingly common tumor in the U.S. and around the globe. According to the National Cancer Institute, approximately 40,710 people will be diagnosed with liver cancers in 2017 and approximately 28,920 will die of these diseases. HCC is a primary malignancy of the liver and the most common form of liver cancer. Bayer,s Nexavar was approved for the treatment of advanced hepatocellular (liver) cancer approximately 10 years ago.
Bayer has invested a lot of time and effort into studying the disease, and used its past experiences to develop better trial design and come up with Stivarga. The FDA's approval of Stivarga was based on results from a randomized trial of 573 patients with progressive hepatocellular (liver) cancer. According to an expert in Bayer's Oncology Clinical Development wing, liver cancer is unique in that it exhibits heterogeneity at the molecular level, and as such researchers have not been able to recognize a single predominant key driver, pathway, or mutation to pursue.
Bayer overcame these challenges by carefully crafting the participant eligibility criteria based on what was known about the disease and the safety profile of the investigational drug. The company collaborated closely with physicians and investigators to identify which patient groups would exhibit the highest likelihood of benefiting from Stivarga.
Bayer's Stivarga is a kinase inhibitor that works by blocking several enzymes that promote cancer growth, including enzymes in the vascular endothelial growth factor pathway. Stivarga is also approved to treat colorectal cancer and gastrointestinal stromal tumors that are no longer responding to previous treatments.
In a press release, Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research and director of the FDA's Oncology Center of Excellence said, "Limited treatment options are available for patients with liver cancer," said "This is the first time patients with HCC have had an FDA-approved treatment that can be used if their cancer has stopped responding to initial treatment with sorafenib."