FDA approves oral kidney cancer treatment | VailDaily.com

FDA approves oral kidney cancer treatment

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.”We believe this represents, from a medical point of view, truly a major advance,” Dr. Richard Pazdur, director of the Food and Drug Administration’s Office of Oncology Drug Products, said in a conference call with reporters.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, Pazdur said, 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.About 102,000 people worldwide die from kidney cancer every year.In the U.S., about 32,000 people are diagnosed with the disease each year. It accounts for 3 percent of all adult cancers. It occurs most often in people aged 50 to 70, twice as often in men than in women. Detected early, it can be cured with removal of a kidney, but there have been few effective treatment options for people in whom the disease has spread.Nexavar, taken orally twice a day, works by targeting a tumor’s blood supply and growth, the developers said in a statement.A month’s supply of the drug will have a wholesale price of about $4,300, according to a Bayer spokeswoman. It will be available almost immediately. The drug is being studied to see if it inhibits other kinds of cancer.The primary trial for the drug involved 900 people – 450 of whom took Nexavar, the rest taking a placebo.About 2.9 percent of the people taking the drug developed heart problems – about seven times that of people taking the placebo. Dr. Susan Kelley, vice president of oncology product development at Bayer, said some of the heart problems included heart attacks. She could not provide a more specific breakdown.The companies said people on the treatment should have their blood pressure monitored for at least six weeks, and that high blood pressure was a possible side effect.About 40 percent of the patients on Nexavar had diarrhea and other gastrointestinal side effects, but FDA officials said those were generally manageable and that the drug had fewer toxic side effects than other cancer treatments.Other side effects include rash and blisters on the palms of the hands or soles of the feet.”This is clearly a watershed event in the kidney cancer community,” said Bill Bro, CEO of the Kidney Cancer Association. Slowing the spread of the disease may allow “being able to take a vacation that you always wanted to take, or to be around for a kid’s high school graduation.”Bro, who had his cancer cured with the removal of a kidney, said the fact the new treatment can be taken orally, instead of intravenously, will expand of base of people who can receive treatment for the disease.—On the NetKidney Cancer Association: http://www.kidneycancerassociation.orgFDA: http://www.fda.gov

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