FDA approves 1st treatment for liver cancer in decade
The U.S. Food and Drug Administration Thursday expanded the approved use of Stivarga (regorafinib) for the treatment of patients with hepatocellular carcinoma (HCC), or liver cancer.
This is the first FDA-approved treatment for a liver cancer in almost 10 years. The FDA granted the approval of Stivarga to Bayer HealthCare Pharmaceuticals Inc.
According to the National Cancer Institute, about 40,710 people will be diagnosed with liver cancers in 2017, and approximately 28,920 will die of these diseases. HCC is the most common form of liver cancer.
“Limited treatment options are available for patients with liver cancer,” said Richard Pazdur, M.D., an acting director at the FDA’s Oncology Center of Excellence. “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.”
Stivarga is a kinase inhibitor that is effective by blocking several enzymes, including the vascular endothelial growth factor pathway that promotes cancer growth. Stivarga is also approved to treat colorectal cancer and gastrointestinal stromal tumors when previous treatments are no longer effective.
The efficacy and safety of Stivarga for the treatment of HCC were studied in a randomized trial of 573 patients with HCC whose tumors had developed after receiving sorafenib. The trail measured the overall survival of patients after receiving treatment, the length of time tumors did not grow after treatment and the overall response rate of patients whose tumors shrank after treatment.
Common side effects of Stivarga include gastrointestinal and abdominal pain, fatigue, diarrhea, hand-foot skin reaction, decreased appetite, high blood pressure, infection, dysphonia (difficulty speaking), high levels of bilirubin in the blood, weight loss, fever, mucositis, rash, and nausea.
Serious risks are associated with Stivarga, including liver damage, infections, hemorrhage, holes in the stomach or intestines, skin damage, hypertension, problems with blood flow to the heart, temporary brain swelling, and would healing complications.
Women who are pregnant or breastfeeding should not take Stivarga because it may cause harm to a developing fetus or a newborn baby. Women and men who are taking Stivarga should use effective contraception during and for two months after taking the final dose.
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