New drug approved for soft tissue sarcomas


For decades, there hasn't been a new drug approved for sarcoma, but on April 26, the Food and Drug Administration approved Votrient (pazopanib) for patients with advanced soft tissue sarcoma who have received at least one prior chemotherapy treatment. However, the drug is not for patients who have adipocytic soft tissue sarcoma and gastrointestinal stromal tumors (GIST). Votrient was previously approved in 2009 for advanced renal cell carcinoma.There are two main types of sarcomas--those that develop in the bones and those that develop in the soft tissues of the body, such as fats, muscles, nerves and more. Soft tissue sarcomas can occur anywhere in the body, but most develop in the arms or legs. While there are around 50 different subtypes, only about 11,000 cases are diagnosed each year, making this a rare tumor-type. Votrient is a tyrosine kinase inhibitor that works by inhibiting proteins that either help with the growth of new blood vessels that feeds these tumors or tell the tumor cells to grow and divide. It's a tablet taken once a day, without food, so either an hour before or two hours after a meal.The drug was approved based on a phase 3 randomized, multicenter trial in which 369 patients were assigned to either receive Votrient or a placebo. Those in the Votrient arm had a median of 4.6 months progression free survival compared with the 1.6 months for those on placebo. Trending to improvement over the interim results announced at last year's meeting of the American Society of Clinical Oncology, median overall survival was still insignificant: 12.6 months for those on Votrient and 10.7 months for patients on placebo.Common side effects included diarrhea, nausea, vomiting, decreased appetite and weight loss, hypertension, hair and skin changes, tumor pain, musculoskeletal pain, headache, shortness of breath, taste changes and fatigue, among others. Votrient also carries a boxed warning for the potential risk of liver damage, which can sometimes be fatal, so patients should be monitored for liver function. Other serious side effects include hemorrhage, gastrointestinal perforation, perforated lung and thrombotic events, such as a heart attack.Other drugs in development for sarcomas include ridaforolimus, which was rejected by the same advisory panel that recommended Votrient for approval, ombrabulin, brivanib and Yondelis.For more information, visit call 888-825-5249.

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