FDA approves Bayer's Stivarga for gastrointestinal stromal tumors

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the digestive system, the agency said Monday.

The FDA announced the approval of Stivarga (regorafenib) for gastrointestinal stromal tumors that could not be removed through surgery or had spread to other parts of the body and were no longer responding to treatment with Novartis' Gleevec (imatinib) or Pfizer's Sutent (sunitinib).

Gastrointestinal stromal tumors, or GIST, occur when cancerous cells form in the tissues of the gastrointestinal tract. According to the National Cancer Institute, part of the National Institutes of Health, an estimated 3,000 to 6,000 new cases of GIST occur annually in the United States, most often in older adults.

Stivarga was approved for treating colorectal cancer in September 2012.