Every day in the office, as a practicing prostate oncologist, I confront serious problems: PSA levels that are rising, treatments causing too many side effects, patients desperately worried about their future. And sometimes, given our limited tools, the solutions we can offer are only partial. However, every time the FDA approves a new treatment there is an excitement akin to opening gifts on Christmas morning. All of a sudden we have a shiny new tool in the tool chest to help us do a better job.
I’ve repeatedly gone on record criticizing the FDA for the inflexible format they use to approve any new drug. They insist on survival as the only important measure of effectiveness. There has to be a better way to study new drugs than giving a placebo—an inert substance containing no active ingredient—to unfortunate people who already have a life-threatening illness. But this is the format our government demands—forcing pharmaceutical companies to prove that their new anti-cancer drug works by comparing them with sugar pills. And so the human sacrifices continue.
However, back to the good news, the spirit of Christmas morning. Medivation, the manufacturer of MDV-3100, a new drug that is estimated to be twenty times more potent than Casodex, recently reported a significant survival advantage in their study comparing MDV to the of unfortunate souls who got placebos. In other words, Medivation cleanly jumped over the bar set by the FDA. Since MDV-3100 was not associated with any unexpected side effects, the FDA will be essentially forced to hold up its end of the bargain and release it soon for commercial use.
Some are saying that MDV is just a copycat of Zytiga, one more expensive testosterone blocking pill in an already busy marketplace. I disagree completely:
1. Since MDV has few side effects, it can be easily combined with other popular treatments like Provenge and Taxotere.
2. Since the mechanism of testosterone blockade is completely different from Zytiga, it’s possibly that the anticancer effects of Zytiga and MDV will multiplied if they are given together.
3. Due to its ease of use, it will be popular with the urologists, the surgeons who are charged with managing most men with prostate cancer.
My “Christmases” seem to get better every year. Last year the tool chest was expanded to include Zytiga, Provenge and Jevtana. And there are also some amazing new drugs waiting in the wings—Ipilimumab, Dasatinib, XL-184, Revlimid and more. We finally seem to be entering a new, hopeful era for prostate oncologists—and, most important, for their patients.