U.S. Food and Drug Administration approval of the anti-cancer drug Stivarga (regorafenib) has been expanded to include liver cancer, the agency said Thursday in a news release.
Stivarga, among a class of drugs called kinase inhibitors, is designed to block enzymes that foster cancer growth. It’s the first drug approved to treat liver cancer in nearly a decade, the FDA said.
“Limited treatment options are available for patients with liver cancer,” said Dr. Richard Pazdur, acting director of the agency’s Office of Hematology and Oncology Products. The drug was approved for people with liver cancer treated previously with the drug sorafenib.
More than 40,000 people in the United States are projected to be diagnosed this year with liver cancer, and nearly 29,000 will die from it, the National Cancer Institute estimates.
Stivarga is already FDA approved to treat colorectal cancer and gastrointestinal stromal tumors, the agency said.
The drug’s effectiveness for treating liver cancer was evaluated in clinical studies of 573 people whose tumors had progressed despite being given sorafenib. The most common side effects included gastrointestinal and abdominal pain, skin reactions, fatigue, diarrhea, loss of appetite, high blood pressure and infection. More serious risks included liver damage, heavy bleeding, gastrointestinal ulcers and problems with blood flow to the heart.
Women who are pregnant or breastfeeding shouldn’t take Stivarga, the FDA said. And both genders of child-bearing age who take the drug should use contraception, the agency added.
Approval of Stivarga was granted to Bayer HealthCare Pharmaceuticals, based in Whippany, N.J.
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