New Prostate Drug Refused By FDA

In Washington some cancer patients are running out of hope and time and they are trying to protest against the FDA’s refusal to approve a revolutionary new treatment for advanced prostate cancer.

The FDA, often accused of approving drugs too quickly, is being blasted for not green-lighting the cancer drug called Provenge.

Jim Lanpher is 60-years-old and dying of prostate cancer. His medications no longer work. All his hopes were pinned on this cutting edge, experimental treatment. Then he heard the FDA would not approve it.

“My initial reaction was, ‘oh, no. Oh, please, no.’ I thought I had something almost within my grasp,” Lanpher explained.

“There are so many men around this country that are livid. They’re angry that this drug has not been approved,” said Steve Fleishcmann, prostate cancer patient.

This unique treatment, called Provenge, is custom-made for each patient. It re-focuses the body’s immune system to fight prostate cancer.

“It turns your own ‘t-cells,’ part of your immune system, against your own cancer cells,” clinical investigator, Dr. Roy Berger explained.

It’s targeted and individualized. In early clinical trials, men with advanced prostate cancer who took Provenge lived four-and-a-half months longer, but that’s the average. For some men there was an extra two or three years of life and the only side effects were mild, flu-like symptoms.

It impressed this government advisory panel so well, it recommended 13 to four that Provenge be approved, but the FDA is not convinced.

Agency officials declined to be interviewed, but some doctors have complained the initial studies did not show the treatment actually slows the growth of tumors and that any survival benefit in those small studies might be some statistical fluke.

So the FDA has ordered more testing. That means desperate cancer patients will have to wait another year, at least, before they might get this treatment.

“Everyday there are fellows dying of advanced prostate cancer and none of us can wait that long. We need to move now or some of us won’t be here,” Lanpher said.

But the FDA needs “proof,” and for men running out of time and hope, the wait is agonizing.