Expanded FDA Approval

Bayer Cancer Drug Gains Expanded Approval By FDA

A Bayer cancer drug gained expanded approval today by the US Food and Drug Administration. The drug, named Stivarga, gained clearance as treatment for certain patients affected with gastrointestinal stromal tumors (GIST).

Classified as a tumor in which cancerous cells form in the tissues of the gastrointestinal tract, the disease affects roughly 3,000 to 6,000 new patients in the US each year.

The expanded approval clears way for Stivarga to be used by advanced-stage GIST patients whose tumors are inoperable or have spread to other parts of the body.

The drug was also approved for use in GIST sufferers who no longer respond to standard approved treatments such as Gleevec or Sutent.

Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the Food and Drug Administration’s Center for Drug Evaluation and Research said the following in today’s announcement:

“Stivarga is the third drug approved by the FDA to treat gastrointestinal stromal tumors. It provides an important new treatment option for patients with GIST in which other approved drugs are no longer effective.”

From the German chemical and pharmaceutical company Bayer, the cancer drug works as a multi-kinase inhibitor, blocking enzymes that promote cancer growth.

In today’s announcement, the Food and Drug Administration stated the following:

“Stivarga was reviewed under the FDA’s priority review program, which provides an expedited six-month review for drugs that may provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products. The drug was also granted orphan product designation because it is intended to treat a rare disease.”

In September, Bayer’s cancer drug Stivarga was also approved by the Food and Drug Administration for advanced colorectal cancer patients whose disease progressed after standard therapies.