In the News – FDA Rejects Proscar and Avodart for Prevention of Prostate Cancer
Snippet from the article:
An FDA advisory committee has voted against approval of two drugs for the prevention of prostate cancer because of a link to increased risk of high-grade, aggressive forms of the disease.
GlaxoSmithKline’s Avodart and Merck’s Proscar are approved to treat benign prostatic hyperplasia (BPH), or enlarged prostate, which is common among men over the age of 50. In studies, both drugs showed a nearly 25% reduction in the risk of developing low-grade forms of prostate cancer compared to participants taking a placebo.
FDA medical officer Yang-Min Ning, MD, PhD, says such forms of cancer “propose very little threat to men during their lifetime.â€
Read the full text at WebMD — FDA Panel Rejects Drugs to Prevent Prostate Cancer
There is a great deal of politics going on that I really do not understand, but even with this panel rejection, I would not advise my own son to stop taking 1mg finasteride to treat his hair loss.
It is clear that finasteride at the 5mg dose seems to prevent prostate cancer to some degree, but it wasn’t enough for the FDA to label it as a preventive medication for prostate cancer. People will ultimately need to make their own decisions in regards to this medication, but keep in mind that at the 1mg finasteride dose that is prescribed to treat hair loss, there is really no evidence one way or the other that it could be a problem or even if it will prevent prostate cancer. More will be written by other societies and I will fill in the readers of this site once we know where it all “falls out”.
Does this change you opinion regarding a 1.25 mg dose (generic Proscar in fourths)?
Jack,
No, because I’m not prescribing 1.25mg to my patients to treat prostate cancer. Finasteride and dutasteride are both still approved to treat BPH (and finasteride 1mg for treating hair loss), but the FDA just didn’t give them the green light to be listed as prostate cancer prevention medications.
As I understand this issue, there is little doubt that Finasteride can be effective at preventing prostate cancer. However, the concern is that 5mg Finasteride has a possible correlation with the appearance of more aggressive forms of prostate cancer.
This is not a decision by the FDA, but an independent Advisory Committee composed of 17 members – mostly from academic institutions (oncologists, statisticians, epidemiologists, etc). The FDA often follows the recommendations of advisory committees, as the committees’ recommendations are presumably “data-driven†and the FDA typically comes to similar conclusions. However, as in the case of many decisions that are split or where significant differences in interpretation of risk-benefit exist, the FDA has occasionally approved or rejected a drug against the recommendation of an advisory panel.
The Oncology Advisory Committee voted 17-0 against expanding the label for finesteride to include prevention of prostate cancer. A unanimous vote by FDA Advisory Committees is rare. I have no special knowledge of the meeting. This decision was presumably based in part on data from the 19,000 patient Prostate Cancer Prevention Trial and the belief that the data did not support the risk benefit profile (i.e. possibility of increased aggressiveness of tumor did not outweigh reduced risk of low-grade tumors). As with all such committee meetings, which are open to the public (including listening via live webcasts), the transcript will be published and available within a few weeks at the FDA’s web site (www.fda.gov).