FDA Approves Stivarga (Regorafenib) for Liver Cancer

The US Food and Drug Administration (FDA) has expanded the approved use of the targeted therapy drug Stivarga (regorafenib) to treat liver cancer. Stivarga had already been approved to treat colorectal cancer and gastrointestinal stromal tumors. This is the first FDA approval for a liver cancer drug in nearly a decade. It’s for people whose liver cancer has stopped responding to the targeted drug Nexavar (sorafenib).

Stivarga works by blocking proteins on or near the surface of a cell that help cancer cells grow, as well as proteins that help form new blood vessels to feed growing tumors.

The FDA based its approval on a clinical trial of 573 people with liver cancer whose tumors grew after they were treated with Nexavar. Those who received Stivarga lived for an average 10.6 months compared to 7.8 months for those who did not. In addition, those who received Stivarga went about 1 ½ months longer without their cancer getting worse than those who did not.

The FDA evaluated Stivarga under its priority review program, in which the FDA tries to make a decision within 6 months instead of the usual 10 months. The drug was also granted orphan product designation, which provides incentives to the drug’s developers because it is intended to treat a rare disease.

The most common side effects of this drug include weakness and fatigue, pain and redness in the hands and feet, rash, diarrhea, loss of appetite, nausea, weight loss, high blood pressure, mouth sores, infection, voice changes, stomach pain, and fever.

Rare, but serious, side effects can include liver damage, severe bleeding, blistering and peeling of skin, very high blood pressure, heart attack, perforated intestines, and swelling in the brain.

Women who are pregnant or breastfeeding should not take Stivarga because it may cause harm to a developing fetus or a newborn baby. Both women and men who are taking Stivarga should use birth control during and for 2 months after taking the final dose.

Stivarga is marketed by Bayer HealthCare Pharmaceuticals.

The American Cancer Society medical and editorial content team

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