FDA approves Stivarga for GI stromal tumors

FDA Approves Expanded Use of Stivarga for GI Stromal Tumors
FDA Approves Expanded Use of Stivarga for GI Stromal Tumors

(HealthDay News) -- The U.S. Food and Drug Administration has approved the expanded use of the multi-kinase inhibitor Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and do not respond to other treatments. The drug was granted orphan product designation because it is intended to treat a rare disease.

The FDA approval was based on data from a clinical study of 199 patients with inoperable or metastatic GIST who progressed in spite of treatment with FDA-approved Gleevec (imatinib) and Sutent (sunitinib). The patients were randomized to receive Stivarga or placebo, and also received optimal supportive care. Patients allocated to receive Stivarga had a 3.9 month delay in tumor growth compared with placebo.

The most common side effects seen with Stivarga included weakness and fatigue, hand-foot syndrome, diarrhea, loss of appetite, nausea, stomach pain, weight loss, hypertension, mouth sores, rash, fever, changes in voice volume or quality, and infection. In addition, serious side effects, noted in less than 1 percent of patients, included liver damage; severe blistering, bleeding, and peeling of skin; very high blood pressure; heart attack; and intestinal perforation. Stivarga was approved in September 2012 to treat colorectal cancer.

Stivarga is marketed by Bayer HealthCare Pharmaceuticals, based in Wayne, N.J.

More Information

Loading links....
You must be a registered member of ONA to post a comment.

Sign Up for Free e-newsletters

Regimen and Drug Listings


Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Genitourinary Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Rare Cancers Regimens
Skin Cancer Regimens Drugs