WASHINGTON – A new treatment that slows the spread of advanced kidney cancer won government approval Tuesday, offering potential relief from a disease that kills 12,000 Americans a year.
It’s the first new treatment option for kidney cancer patients in more than a decade.
In trials, patients treated with Nexavar, also known as sorafenib tosylate, went longer without their cancer progressing than those taking a placebo. The drug was developed by Bayer and Onyx Pharmaceuticals.
The medicine is for patients with advanced renal cell carcinoma, the most common type of kidney cancer. The FDA said that in one trial, patients taking the drug went twice as long – a median of six months versus three months for those taking a placebo – without the cancer progressing or the patient dying.
“Rarely do we see a 100 percent improvement” in a new cancer treatment, said Dr. Richard Pazdur, director of the Food and Drug Administration’s Office of Oncology Drug Products, citing those figures.
The companies said people taking the drug also lived longer, although FDA officials said it was too soon to say conclusively that was the case.
In the U.S., about 32,000 people are diagnosed with the disease each year.
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