Votrient Treating Advanced Soft-Tissue Sarcoma

Soft tissue sarcoma drug receives FDA approval

/ Author:  / Reviewed by: Robert Carlson, M.D

(RxWiki News) It usually starts as a lump under the skin that doesn't hurt or cause any real symptoms. Soft-tissue sarcoma usually shows up on an arm or leg, and it's very treatable if caught early.

The U.S. Food & Drug Administration (FDA) has approved a new drug - Votrient (pazopanib) - for  treating advanced soft-tissue sarcoma, a cancer that appears in muscle, fat or connective tissues.

"See your doctor if you have a lump that doesn't go away."

This is the first drug that's been approved to treat this rare cancer in decades.

“Soft tissue sarcomas are a diverse group of tumors and the approval of Votrient for this general class of tumors is the first in decades,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Soft-tissue sarcoma will be diagnosed in just over 11,000 men, women and children in this country this year, according to the American Cancer Society.

The newly approved medication is taken by mouth and will be prescribed for use following chemotherapy. It's already being used for advanced forms of kidney cancer.

Votrient's approval is based on a clinical trial with 369 patients. The drug temporarily slowed tumor growth, but there's no data about whether or not it extends life.

The most serious side effect of the medication is potentially fatal liver damage. As a result, liver function needs to be carefully monitored in all patients on the drug. 

Votrient is manufactured by GlaxoSmithKline.

Reviewed by: 
Review Date: 
April 26, 2012
Last Updated:
April 29, 2012