FDA stamps approval on GSK cancer drug Votrient

GlaxoSmithKline ($GSK) has scored a new U.S. approval for Votrient, making the drug the first new treatment for cancers called soft tissue sarcomas in decades. The FDA nod follows a study that showed that patients on Votrient lived three months longer than those on a placebo without their cancer getting worse, the agency said.

That 369-patient trial involved patients who had previously gotten chemotherapy. While chemotherapy works like a broad sword against tumors, Votrient is designed to inhibit the growth of tumor blood vessels that sustain cancers. Still, some common side effects in patients on the drug included fatigue, diarrhea, nausea and weight loss, among others. And the FDA's approval comes with a boxed warning that the drug can cause potentially fatal liver damage, noting that liver function should be monitored in patients on the treatment.

This approval isn't much of a surprise. An FDA advisory panel last month backed approval of the drug for treating soft tissue sarcomas, which are cancers rooted in muscle, fat, fibrous and other tissues. About 10,000 cases of the diverse cancer are diagnosed in the United States annually, according to the FDA. U.S. regulators previously gave Votrient orphan status, which means that GSK gets 7 years of market exclusivity for the treatment, Reuters reported. The drug, which has a previous nod for treating kidney cancer, was tested in more than 20 subtypes of soft tissue sarcomas.

"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," Dr. Richard Pazdur, the FDA's director of the Office of Hematology and Oncology Products, said in a statement. "Drug development for sarcomas has been especially challenging because of the limited number of patients and multiple subtypes of sarcomas." 

- here's the FDA's release
- and the Reuters article

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