US FDA approves Stivarga for liver cancer treatment

The US Food and Drug Administration (FDA) had widened the indication for regorafenib (Stivarga, Bayer) to now include treatment for patients with hepatocellular carcinoma (HCC) who had earlier been treated with the drug sorafenib (Nexavar, Bayer).

The approval marked the first FDA-approved treatment for liver cancer in almost a decade.

"Limited treatment options are available for patients with liver cancer," Richard Pazdur, MD, 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 in a statement.

"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," said Dr Pazdur.

Regorafenib, an oral multikinase inhibitor, was already approved for the treatment of metastatic colorectal cancer and for use in the treatment of gastrointestinal stromal tumors that could not be surgically removed and no longer responded to imatinib (Gleevec, Novartis) and sunitinib (Sutent, Pfizer), FDA stated in a press release.

FDA said the approval for the use of the drug in liver cancer was based on the results of a phase three randomised trial that included 573 patients with progressive HCC who had earlier been treated with sorafenib.

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 originates in the liver and was the most common form of liver cancer.

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.