The US Food and Drug Administration (FDA) approved the oral agent pazopanib (Votrient; GlaxoSmith-Kline) for the treatment of patients with advanced soft-tissue sarcoma who have previously received chemotherapy. Pazopanib received orphan drug designation for this indication and is the first agent to receive approval for this indication in many years. Votrient works by interfering with the angiogenesis process (ie, the growth of new blood vessels that feed the growth/survival of solid tumors).
Soft-tissue sarcoma is a rare type of cancer that begins in muscle, fat, fibrous tissue or other tissues and has many subtypes; it occurs in approximately 10,000 cases annually in the United States. More than 20 subtypes of sarcoma were included in the clinical trial leading to the approval of this drug. Pazopanib is not approved for patients with adipocytic soft-tissue sarcoma or gastrointestinal stromal tumors.
The most common side effects in patients receiving pazopanib were fatigue, diarrhea, nausea, weight loss, high blood pressure, decreased appetite, vomiting, tumor and muscle pain, hair color changes, headache, a distorted sense of taste, shortness of breath, and skin discoloration.
Votrient carries a boxed warning regarding the potential risk for hepatotoxicity, which can be fatal. Patients should be monitored for liver function, and the drug should be stopped if liver function declines. This agent is already approved for the treatment of advanced kidney cancer. (April 26, 2012)
