Sep 24, 2014

OHSU led Prostate Cancer Clinical Trial results in FDA approval

This is a reprint of an article from the  Portland Oregonian, written by Nick Budnick

A prostate cancer drug spearheaded by Oregon researchers has received federal approval based on studies showing it prolongs life without chemotherapy.

Enzalutimide was approved for prostate cancer under the name Xtandi® two years ago, but was authorized only for patients who were already on chemotherapy.

Now, the Food and Drug Administration has approved the drug for a new group of patients based on trials overseen by Knight Cancer Institute at Oregon Health & Science University.
The drug slows the disease, it doesn't cure it. However, the pill's expanded approval is significant for prostate cancer sufferers, many of whom never enter chemotherapy. Some don't care to undergo chemo's debilitating side effects, and some older patients are too vulnerable to even try.

The study found that the average treatment time on the daily pill – meaning until chemotherapy was deemed medically appropriate -- was 16 months, said Tomasz Beer, the institute's deputy director who oversaw the trials. Subsequent data suggests the period may be as long as 19 months.

In contrast, the average time before chemotherapy was required for people on the placebo pill was about four months.

"It's buying you close to a year and a half where your cancer is controlled by a pill," Beer said.

The drug also lowered the likelihood of death by 30 percent at any one time, according to trial results. The study was conducted on more than 1,700 patients in numerous countries including the United States, Canada, Europe, Australia, Russia, and Japan.

Treatment costs are about $7,500 a month.

Post Text Here
To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker