Men whose prostate cancer has metastasized to the bone may have access to a new drug treatment that helps significantly extend their life by mid-year 2012.
In August, the U.S. Food and Drug Administration agreed to fast-track Alpharadin based on the drug’s performance in a Phase III study.
The Phase III study was so successful that researchers stopped it early, saying that the evidence that the drug extends a cancer patient’s life was so noticeable that it was unethical not to treat all of the study participants.
To say that this is an exciting development for those with advanced prostate cancer and their families is an understatement, and the FDA appears to agree. This fast-track designation is given by the FDA to facilitate the development or expedite the process of getting drugs that treat unmet needs to patients more quickly.
How Does it Work?
Alpharadin is a radioactive drug that uses Alpha particles—rather than slower-working beta particles—to break down the DNA and some molecules inside cancerous cells.
These Alpha particles have several benefits over beta particles: one, they are smaller than beta particles, which means they can target a cancer cell without injuring healthy cells nearby. They’re also more effective bullies—it’s possible for these particles to destroy DNA and other molecules in the cancer cell with two or three targeted hits, rather than the hundreds or thousands of hits needed by beta particles.
How Does it Help?
Studies by the drugmakers suggest it prolong survival by three to four months—a time period that is no doubt priceless to patients and their families. Interestingly, the clinical trials also found that patients who took Alpharadin had fewer side effects when they took the drug plus traditional chemotherapy than patients who had chemotherapy and a placebo.
Published On: November 21, 2011