Last week, Votrient (pazopanib), a drug used to treat patients with advanced soft tissue sarcoma who have previously received chemotherapy, was approved by the FDA. Pazopanib is a pill that works by interfering with angiogenesis.
Soft tissue sarcoma is a rare cancer with many subtypes; it occurs in about 10,000 cases annually in the United States. More than 20 subtypes of sarcoma were included in the clinical trial leading to approval of pazopanib, however, the drug is not approved for patients with adipocytic soft tissue sarcoma and gastrointestinal stromal tumors.
“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. “Drug development for sarcomas has been especially challenging because of the limited number of patients and multiple subtypes of sarcomas.”
In a single clinical study designed to measure the length of progression-free survival, pazopanib was evaluated in 369 patients with advanced soft tissue sarcoma who had received prior chemotherapy. Patients were randomly selected to receive pazopanib or a placebo. For patients receiving pazopanib, the disease did not progress for a median of 4.6 months. However, those receiving the placebo were progression-free for only 1.6 months.
The most common side effects in pazopanib-treated patients 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.
Due to the potential risk of hepatotoxicity when taking pazopanib, patients should be monitored for liver function, and treatment should be discontinued if liver function declines.
Source: FDA.