FDA Approves New Drug For Treating Liver Cancer
The U.S. Food and Drug Administration has approved the drug Stivarga (Regorafenib) for the effective second-line treatment of patients affected with liver cancer.
Stivarga is a product of German-based pharmaceutical company Bayer HealthCare Pharmaceuticals Inc. The company has been seeking FDA approval for the drug for a long time. In November 2016, Bayer had applied to the FDA for the approval of Stivarga post its successful clinical trials for treating hepatocellular carcinoma, or liver cancer.
"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," the FDA's Richard Pazdur remarked.
Stivarga: How It Works On Cancer Patients
Stivarga acts as a kinase inhibitor in liver cancer patients who have been treated with sorafenib. The second-line drug protects the patient by blocking many enzymes that fuel cancer cell growth. Apart from these, Stivarga will also block enzymes present in the "vascular endothelial growth factor pathway."
The drug has also received a green signal from the FDA for treating gastrointestinal stromal tumors and colorectal cancer, which are not responding to previous treatment any longer.
The efficiency and safety of Stivarga was established in a randomized clinical trial involving 573 patients of liver cancer, whose tumors did not respond to the treatment of sorafenib. It was observed that the trial patients taking Stivarga had a median overall survival of 10.6 months vis-à-vis the 7.8 months for patients consuming a placebo.
Stivarga: Side Effects And Risks
The known common side effects of Stivarga include diarrhea, abdominal and gastrointestinal pain, fatigue, hand-foot skin reaction, dysphonia, reduced appetite, hypertension, inflammation of the mucous membranes, fever, weight loss, nausea, infection, and rash.
Although the safety of the drug has been established, its usage comes associated with some serious risks such as infections, liver damage, hemorrhage, dermatologic toxicity, gastrointestinal perforation or fistula, temporary brain swelling, hypertension, cardiac ischemia and infarction, as well as complications in wound healing.
The FDA also cautions pregnant and breastfeeding women against the consumption Stivarga as it may harm the fetus. The agency also advised men and women consuming Stivarga to use "effective contraception" when taking the medicine, as well as two months after its final dose.
Liver Cancer In The United States
According to the Centers for Disease Control and Prevention, roughly 8,000 women and 21,000 men fall victim to liver cancer in the U.S. each year. Nearly 8,000 women and 16,000 men die of the ailment each year.
The rate of Americans contracting liver cancer has been increasing for several decades. The CDC advises individuals to vaccinate themselves against Hepatitis B to lower the risk of getting liver cancer. Moreover, people should also get tested for Hepatitis C and reduce their alcohol consumption to steer clear from liver cancer risk.
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