FDA Approves New GIST Rx

Stivarga receives FDA approval to treat GIST

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) The US Food and Drug Administration has approved a medication to treat gastrointestinal stromal tumors (GIST) that can’t be removed with surgery, have spread or no longer respond to existing therapies.

Stivarga (regorafenib) blocks several enzymes that encourage cancer growth.

The new medication offers GIST patients another option after the disease no longer responds to Gleevec (imatinib) and Sutent (sunitinib), the other two FDA approved GIST therapies.

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GIST forms in the soft tissues of the gastrointestinal tract, which is part of the body’s digestive system. About 4,500 adult Americans will be diagnosed with GIST this year. These tumors appear mostly in the stomach and small intestine.

This approval is based on safety and effectiveness study involving 199 GIST patients. Study participants all had cancers that couldn’t be removed and the disease progressed after treatment with Gleevec or Sutent.

Study members, all of whom received optimal supportive care to treat cancer symptoms, were randomly assigned to either take either Stivarga or a placebo. Patients in the Stivarga group saw their disease progress about 4 months later than individuals in the placebo group.

Patients in the placebo group were able to switch to Stivarga when their disease progressed.

The most common side effects reported in patients treated with Stivarga were weakness and fatigue, hand-foot syndrome, diarrhea, loss of appetite, high blood pressure, mouth sores, infection, changes in voice volume or quality, pain, weight loss, stomach pain, rash, fever and nausea.

Serious side effects, which occurred in less than 1 percent of patients, were liver damage, severe bleeding, blistering and peeling of skin, very high blood pressures requiring emergency treatment, heart attacks and perforations (holes) in the intestines.

Stivarga was approved in September 2012 to treat colorectal cancer.

The medication costs $9,350 for a 28-day supply. Bayer offers patient assistance through the Bayer REACH® (Resources for Expert Assistance and Care Helpline) program -- 1-866-639-2827.

Stivarga is marketed by Bayer HealthCare Pharmaceuticals, based in Wayne, NJ. Gleevec and Sutent are marketed by Pfizer.

Reviewed by: 
Review Date: 
February 25, 2013
Last Updated:
January 2, 2014