A federal cancer advisory panel on Tuesday backed the approval of GlaxoSmithKline’s cancer drug Votrient for treating patients with deadly soft-tissue sarcoma.
Despite some patients taking the pill exhibiting side effects like liver toxicity, high blood pressure and heart problems, a Food and Drug Administration advisory panel voted 11-2 that the "risk benefit assessment" was positive for expanding the use of Votrient, a drug that already on the U.S. market to treat advanced kidney cancer, to treat advanced cases of soft-tissue sarcoma, that develops in muscle or other connective tissues in the body.
Although the FDA is not required to follow its panel's advice, it usually does.
If Votrient, chemically known as pazopanib, is cleared by the FDA, it is expected to be the first targeted treatment for soft-tissue sarcoma that affects soft tissue such as muscle, tendons and fat outside the stomach and intestines, a cancer that is currently treated with chemotherapy.
While Votrient did temporarily slow cancer growth, the FDA said that the pill didn’t appear to prolong patients’ lives.
Data from clinical trials had showed that patients being treated with Votrient had a median progression-free survival of 4.6 months compared with 1.6 months on the placebo, a three-month difference in time before the cancer gets worse.
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.
Researchers also found that more patients on Votrient suffered more serious side effects than patients in the placebo group, such as having higher rates of blood clots in the lungs and heart “dysfunction”.
The panel said that new drugs are needed, even if the benefit only exceeds the risk by a little.
“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, during the meeting, according to Bloomberg. “This is a drug I would like to have in my armamentarium.”
Votrient was approved by the FDA in 2009 to treat advanced renal cell carcinoma, and is expected to decide its approval for use in patients with soft-tissue sarcoma by May 6.
The National Cancer Institute estimates there are about 11,000 cases of soft-tissue sarcomas diagnosed each year.