Votrient Recommended by FDA Panel as First Approved Drug for Sarcoma Cancer

US Food and Drug Administration, Votrient, GlaxoSmithKline, Sarcoma
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Sarcomas are a rare class of tumors for which there are currently no approved drugs for treatment in the United States. Two new medications have been introduced to an FDA panel for consideration but only one, Votrient by GlaxoSmithKline, was recommended as it was found to delay the growth of tumors.

A sarcoma is a type of cancer that develops from certain tissues, like fat, bone or muscle. The two main types of sarcoma are bone sarcomas and soft tissue sarcomas. Votrient (pazopanib) belongs to a class of medications called tyrosine kinase inhibitors which works by slowing or stopping the spread of cancer cells. The drug is being submitted as a potential maintenance treatment for those with soft-tissue sarcoma.

The FDA’s Oncologic Drugs Advisory Committee voted 11-2 that the benefits of Votrient – the slowing of tumor growth or its metastasis to other parts of the body – outweighed its risks, as there are few other treatment options for soft-tissue sarcoma patients. Patients in clinical trials taking Votrient had a median progression-free survival of 4.6 months compared with 1.6 months on placebo.

Unfortunately, however, the drug did not appear to significantly extend overall survival for these patients over those who received standard chemotherapy treatment. The median survival time for patients taking Votrient was 12.6 months, a little less than two months longer than those taking the placebo pill with a survival time of 10.7 months

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Side effects included liver toxicity, high blood pressure, blood clots in the lungs, and heart dysfunction.

"There are no drugs approved by the FDA specifically for this indication and that's what drove my decision to vote yes," said Dr. Mikkael Sekeres of the Cleveland Clinic. “It’s a little step but it’s a little step in a field that’s had nothing,” said panel member Lee Helman, scientific director for clinical research at the National Cancer Institute’s center for cancer research.

The National Cancer Institute estimates that 11,000 people in the United States were diagnosed with soft-tissue sarcoma in 2011. Nearly 4,000 died from the disease.

Another drug presented to the panel for the treatment of sarcoma was Merck’s Taltorvic (ridaforolimus). The group voted 13-1 against the medication saying that its significant side effects, which affected 60% of patients, outweighed any potential benefits. Ridaforolimus only delayed disease progression by about seven weeks and the severe side effects included lung irritation, kidney failure, and high blood pressure.

The US Food and Drug Administration is expected to vote on whether or not to approve Votrient for soft-tissue sarcoma by May 6th, 2012. The drug is already approved in the US for the treatment of advanced kidney cancer and in trials for advanced thyroid cancer treatment. The FDA is not obligated to follow recommendations of advisory committees, but often does.

Source Reference: FDA Oncologic Drugs Advisory Committee, Briefing Document NDA 22-465

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