Tag Archives: Proscar Finasteride Prostate Cancer? FDA Advisory Committee December 1 2010

Check Here | Live-Streaming-Video | Wednesday’s Proscar® FDA Panel

About ten minutes before 8 am EST on Wednesday, I’ll provide a live-stream feed of the video, slides and audio — from inside the Advisory Committee room, meeting on Merck’s Proscar® (finasteride), in Silver Spring, Maryland. [The FDA’s draft agenda has it that Merck’s drug experts will speak, and present, beginning at about 8:15 am EST.]

As I earlier mentioned, here is some of the non-trivial argument for denying reimbursement, per Susan Heavey, writing for Reuters, tonight:

. . . .[FDA] staff, in documents released ahead of a public advisory meeting on Wednesday, said overall, large trials for each of the drugs showed benefits after . . . seven years with Merck’s drug, Proscar — mostly in men with certain grades of the cancer.

They noted that “neither trial was adequately designed and conducted to characterize the ultimate outcomes of interest,” such as death. “In both trials, there was also an unexpected finding of an increased incidence of high-risk prostate cancers among men receiving” the drugs, they added. . . .”

[FDA] advisers will also consider whether the new data should be included on the Proscar’s label, although Merck is not seeking formal approval for wider use. . . .

“The benefit of finasteride for the risk reduction in prostate cancer is uncertain since the observed risk reduction of prostate cancer was present only in the subgroup of participants diagnosed” with certain tumors, FDA staff wrote. . . .

Interestingly, as to finasteride, the type of cancer it was shown to be most likely to shrink is one that is almost never lethal — and some doctors now argue should not be treated aggressively — except in the rarest of cases.

And so, the committee will likely have its hands quite full, here. Stay tuned.

FDA Advisory Panel To Review Proscar® — For Prostate Cancer, Wednesday Morning

I’ll have more later, but I wanted to get this 148 page PDF file of Merck’s background materials — made public this afternoon — out right away. Happy digging!

Here is the FDA meeting announcement:

. . . .On December 1, 2010, the committee will discuss supplemental New Drug Applications (sNDAs) 021319/024, trade name AVODART® (dutasteride) Soft Gelatin Capsules, manufactured by SmithKline Beecham Corporation d/b/a (doing business as) GlaxoSmithKline and 020180/034, trade name PROSCAR® (finasteride) tablets, manufactured by Merck & Co., Inc. The proposed indication (use) for AVODART (dutasteride) is for reduction in the risk of prostate cancer in men at increased risk of developing the disease. The population at increased risk of prostate cancer includes men with an elevated serum prostate-specific antigen (PSA) or men otherwise determined to be at increased risk based on other associated risk factors such as age, race, and family history. There is no proposed expansion of the indication for PROSCAR (finasteride); however, in light of the Prostate Cancer Prevention Trial (PCPT) which demonstrated a statistically significant reduction in the 7-year period prevalence of prostate cancer with finasteride (PROSCAR) treatment, and which reported an imbalance in high Gleason grade prostate cancers (indicating more aggressive cancers) in the finasteride treatment arm vs. placebo, the efficacy and safety of both products for use in prostate cancer risk reduction will be examined. . . .

Back later tonight — board meetings call — but there is a quite-sensible argument to be made that even if approved, this drug ought not be eligible for reimbursement — for this condition.