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Cancer blog: FDA Approves Oral Kidney Cancer Drug

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Dec 20, 2005

FDA Approves Oral Kidney Cancer Drug

FDA Approves Oral Kidney Cancer Drug
Read more about the clinical trial that led to the approval of sorafenib.

FDA has approved sorafenib tosylate (Nexavar) as an oral treatment for advanced kidney cancer today. This is the first kidney cancer drug to receive FDA approval in over one decade.

In clinical trials, patients who were treated with this new oral drug called Nexavar sorafenib tosylate) had doubling of survival compared to those who were receiving placebo. "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 section.

"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 approval is for patients with advanced renal cell carcinoma. 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 drug may have serious side effects. 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.

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.


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Cancer is a very common disease, approximately one out of every two American men and one out of every three American women will have some type of cancer at some point during the course of their life. Cancer is more common in the elderly and 77 percent of cancers occur in people above age 55 or older. Cancer is also common in children. Cancer incidence is said to have two peaks once during early childhood and then during late years in life. No age period is completely exempted from development of cancers. Some cancers occur predominantly in the elderly, other types occur in children, Cancer occurs in all ethnic races, however the cancer rates and rates of specific cancer types may vary from group to group. Late stages of cancer may be incurable in most cases, but with the advancement of medicine, more and more cancers are becoming curable.

Cancer blog: FDA Approves Oral Kidney Cancer Drug

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