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FDA approves Stivarga for liver cancer treatment

The US Food & Drug Administration (FDA) has approved the drug Stivarga (regorafinib) for treatment of hepatocellular carcinoma (HCC) or liver cancer. It is the first FDA-approved treatment for this condition in nearly a decade. Developed by Bayer HealthCare Pharmaceuticals, Stivarga is already approved to treat patients with colorectal cancer and gastrointestinal stromal tumors.

Incidences of liver cancer have more than tripled since 1980 and it is estimated more than 40,000 new cases of primary liver cancer and intrahepatic bile duct cancer will be diagnosed in the US this year, according to the National Cancer Institute. HCC is the most common form of liver cancer and is the third leading cause of cancer-related deaths worldwide. 

"Limited treatment options are available for patients with liver cancer," said 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. People at a higher risk of developing adult primary liver cancer include those with: hepatitis B or hepatitis C, cirrhosis, metabolic syndrome, hemochromatosis and long-lasting liver injury.  

Treatment of liver cancer depends on the stage of the cancer and the individual patient, but a number of different options are available. Surgical options may include removal of the cancerous part of the liver, or a liver transplant. Embolization therapy to block blood flow to the tumor is another possible route. Targeted therapy, using protein kinase inhibitor drugs such as Nexavar (sorafenib tosylate) to attack the cancer cells is one of the most common forms of treatment. 

"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," Pazdur asserted. Stivarga's safety and efficacy was tested in a randomized trials of 573 patients with HCC whose tumors continued to grow following treatment with sorafenib. The response rate among patients taking the drug was 11 percent, more than twice the figure found among patients given a placebo.

Stivarga was granted Priority Review and Orphan Drug designation by the FDA. It is a kinase inhibitor that blocks cancer growth-promoting enzymes. Common side effects of the drug include (among others): pain, fatigue, diarrhea, decreased appetite, hypertension, dysphonia, weight loss, rash and nausea. 

In other cancer treatment news, the FDA recently announced Takeda Pharmaceuticals had been granted approval for Alunbrig as a treatment for certain lung cancer patients. The drug carries Breakthrough status in the US and is a second-line therapy for adult patients with non-small cell lung cancer and the anapestic lymphoma kinase mutation.

See the link below for more information on Stivarga: