National Cancer Institute NCI Cancer Bulletin: A Trusted Source for Cancer Research News
May 1, 2012 • Volume 9 / Number 9

FDA Update

FDA Approves New Drug for Advanced Soft Tissue Sarcoma

The Food and Drug Administration (FDA) last week approved pazopanib (Votrient) to treat patients with advanced soft tissue sarcoma who have previously received chemotherapy. Pazopanib is a pill that works by interfering with angiogenesis, the growth of new blood vessels that solid tumors need to grow and survive.

Soft tissue sarcoma—a rare cancer that begins in muscle, fat, fibrous tissue, and other tissues—is diagnosed in about 10,000 people annually in the United States. More than 20 subtypes of sarcoma were included in the clinical trial that led to the approval of pazopanib. The drug is not approved for patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors.

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

Pazopanib carries a boxed warning alerting patients and health care professionals to the risk of severe or fatal liver damage. Patients should be monitored for liver function, and treatment should be discontinued if liver function declines, the label advises.

Pazopanib was designated an orphan drug for this indication. The designation is given to a drug intended to treat a disease that affects fewer than 200,000 patients in the United States. Pazopanib was first approved in October 2009 for the treatment of advanced kidney cancer.

For more information, see the FDA news release.