Content about Gastrointestinal stromal tumor

February 25, 2013

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.

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).

September 5, 2012

Bayer HealthCare and Onyx Pharmaceuticals are seeking approval for a new drug to treat tumors of the gut, the companies said.

WAYNE, N.J. — Bayer HealthCare and Onyx Pharmaceuticals are seeking approval for a new drug to treat tumors of the gut, the companies said.

Bayer and Onyx announced the submission to the Food and Drug Administration of an application seeking approval for regorafenib in patients with gastrointestinal stromal tumors, or GIST. Bayer developed the drug and formed a partnership with Onyx in 2011, whereby Onyx will receive a royalty on future global net sales of the drug in cancer-related indications. Both companies will promote the drug in the United States.

June 4, 2012

An experimental drug made by Bayer HealthCare extended the length of time that patients with gastrointestinal tumors survived without their disease getting worse, according to results of a late-stage clinical trial released Monday.

WAYNE, N.J. — An experimental drug made by Bayer HealthCare extended the length of time that patients with gastrointestinal tumors survived without their disease getting worse, according to results of a late-stage clinical trial released Monday.

February 1, 2012

The Food and Drug Administration has approved a drug made by Novartis that is designed to prevent tumors in the gastrointestinal tract from recurring after surgical removal, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Novartis that is designed to prevent tumors in the gastrointestinal tract from recurring after surgical removal, the agency said.

The FDA approved Novartis' Gleevec (imatinib) for adults who have had gastrointestinal stromal tumors, or GIST, removed. The drug was specifically approved for people whose tumors are known as CD117-positive, which includes 95% of all GIST tumors.

The drug was originally approved in 2001 for a type of leukemia.

May 23, 2011

The Food and Drug Administration has approved a Pfizer drug for treating pancreatic tumors.

NEW YORK — The Food and Drug Administration has approved a Pfizer drug for treating pancreatic tumors.

Pfizer announced Friday the approval of Sutent (sunitinib malate) for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in patients with locally advanced disease that can’t be removed through surgery. Pancreatic NET is a rare cancer reported in 2 million to 4 million people worldwide every year.

May 10, 2011

The Food and Drug Administration will expedite its review of an investigational drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the gastrointestinal tract, the company said Tuesday.

WAYNE, N.J. — The Food and Drug Administration will expedite its review of an investigational drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the gastrointestinal tract, the company said Tuesday.

March 11, 2010

Two clinical trials of a Pfizer drug for treating advanced breast cancer have failed, Pfizer...