BEIJING, Dec. 21 (Xinhuanet) -- Nexavar, a new drug developed at the University of Chicago, on Tuesday won approval from the U.S. Food and Drug Administration (FDA) for use in treating advanced renal cell carcinoma, the most common form of kidney cancer.
FDA officials said the Bayer and Onyx Pharmaceuticals drug is "a major advance".
Unlike the current standard treatment for kidney cancer - immune therapy with interferon or interleukin-2 - which has only modest benefits but can be extremely toxic, Nexavar has few side effects, and some patients who started taking it more than two years ago are still doing well, researchers said Tuesday.
The manufacturer of Nexavar, Bayer, used X-rays to determine that the drug doubled the time, to 167 days from 84, before tumors grew substantially in number or size.
Nexavar is one of a new generation of anti-cancer agents made possible by advances in molecular biology. Its effects on other types of cancer is also being studied.
Dr. Mark Ratain, chief of clinical pharmacology at the University of Chicago, said the investigators who are conducting a large-scale trial of Nexavar have not yet done a final analysis to see whether patients on Nexavar live longer, "but the interim survival analysis is clearly promising."
"That doesn't mean we want drugs pushed through faster," said the president of the National Breast Cancer Coalition, Frances M. Visco. "It means we want better science, meaningful endpoints and drugs that have less toxicity and actually prolong survival."
According to the American Cancer Society, 32,000 Americans a year are diagnosed with kidney cancer and about 12,000 die of it. Enditem
(Agencies)
|
