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FDA OKs Promising Kidney Cancer Drug

Posted on: Wednesday, 21 December 2005, 12:00 CST

By Judy Peres, Chicago Tribune, Chicago Tribune

Dec. 21--A new-generation cancer drug developed at the University of Chicago won government approval Tuesday for use in treating patients with advanced kidney cancer.

The U.S. Food and Drug Administration said the agent, Nexavar, is a significant step forward. The current standard treatment for kidney cancer--immune therapy with interferon or interleukin-2--has only modest benefits and can be extremely toxic.

The new drug has few side effects, and some patients who started taking it more than two years ago are still doing well, researchers said Tuesday.

Kenneth Vajda, 52, of Naperville was overjoyed when he heard the drug had been approved. He has been taking Nexavar for more than a year. "This is a breeze compared with interferon or interleukin," Vajda said. "I have not missed a day's work on this drug."

Nexavar is one of a new generation of anti-cancer agents made possible by advances in molecular biology. These so-called targeted therapies attack specific features of the cancer cells and generally spare the body's healthy cells. Conventional chemotherapy attacks all rapidly dividing cells, including those in the mouth and the stomach lining. As a result, chemo patients generally suffer severe side effects, such as nausea, vomiting and hair loss.

Vajda was diagnosed with kidney cancer in 1989. Although it responded to standard therapies, the cancer always came back. In 2000 it spread to his lungs and pancreas.

In October 2004, he got into a clinical trial of Nexavar at the University of Chicago.

"I've been on it ever since," he said. " And I really have not had any bad side effects.

Dr. Mark Ratain, chief of clinical pharmacology at the U. of C., 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."

One problem confounding the calculations, he said, is that patients who were taking a placebo were allowed to "cross over" and receive Nexavar if they got worse on the dummy pills. Doctors couldn't ethically withhold the experimental drug once it became clear it was working.

A month's supply of Nexavar will have a wholesale price of about $4,300, according to a spokeswoman for Bayer, one of the developers. It will be available almost immediately.

The drug, developed by Bayer with Onyx Pharmaceuticals, was originally designed to treat colon cancer. It bombed on that disease but ultimately was found to work in a different group of patients.

The drug targets enzymes in the tumor cells and the blood vessels that feed them. It appears to work by stopping cancerous cells from proliferating and also starving the tumor by shutting down its blood supply.

jperes@tribune.com

Tribune wire services contributed to this report

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Source: Chicago Tribune

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