FDA Approves Pazopanib for Advanced Soft-tissue Sarcoma


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The FDA has approved pazopanib (Votrient) to treat patients with advanced soft-tissue sarcoma who have previously received chemotherapy. Pazopanib is an oral agent that works by interfering with angiogenesis.

Soft-tissue sarcoma 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. Pazopanib 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.

Pivotal Trial

The safety and effectiveness of pazopanib was evaluated in a single clinical study in 369 patients with advanced soft-tissue sarcoma who had received prior chemotherapy. Patients were randomly selected to receive pazopanib or a placebo. The study was designed to measure progression-free survival. The disease did not progress for a median of 4.6 months for patients receiving pazopanib, compared with 1.6 months for those receiving placebo.

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.

Pazopanib carries a boxed warning alerting patients and health-care professionals to the potential risk of hepatotoxicity, which can be fatal. Patients should be monitored for liver function and treatment should be discontinued if liver function declines. ■



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