Tag Archives: JAMA New Study Prostate Cancer Monitor Don’t Treat With Proscar Finasteride Prostate Cancer? FDA Advisory Committee December 1 2010

Sun Wins FDA Approval of Generic Version of Merck’s Proscar®, Propecia®


Not a surprise, but news of additional erosion of Merck’s branded legacy drug franchises, Proscar® and Propecia®, here. This approval brings the total of approved generic versions to at least seven; none of which require a prescription, while Merck’s branded offerings still do. Ouch.

The link to the FDA order granting approval to Sun is here. Here is a shortish blurb from a drug industry source, on Mumbai-based Sun’s recent generic approval news:

. . . .Generic drug maker Sun Pharmaceutical Industries has received regulatory approval for a drug designed to treat an enlarged prostate and hair loss in men. . . . Sun Pharma’s finasteride tablets in the 5-mg strength were approved on Aug. 16.

Finasteride is the generic equivalent of Proscar and Propecia, which are made by Merck. . . .

So it goes — as the industry-wide generic/off-patent cliff approaches. Lipitor® (at Pfizer) is next up; the $12 billion a year franchise goes generic in about two months’ time.

Merck’s Proscar® For Prostate Cancer “Not Recommended”: 17-0, At FDA Panel


Not really surprising — given the tenor of the remarks of the FDA staff, this morning. In any event, here is the detail on Proscar® (finasteride) portion of today’s meeting, from a Bloomberg story on it:

. . . .Outside advisers to the Food and Drug Administration voted 17-0 with one abstention today that Proscar has an unfavorable balance of risks and benefits in healthy men at least 55 years old. Merck, based in Whitehouse Station, New Jersey, asked to add data from its studies in prostate cancer to the prescribing information for Proscar, approved in 1992. . . .

Wow — 17-0, huh? — a complete shutout. So it goes.

Proscar® FDA Advisory Committee Meeting Underway — Live Video Feed; Slides


Click right here (you’ll need the latest version of Adobe Reader — it may load it for you), enter as a “Guest” — no password, to watch and listen and follow along. Merck is now finished presently presenting its case for the new indication — from inside the Advisory Committee room, meeting on Merck’s Proscar® (finasteride), in Silver Spring, Maryland.

~ An FDA staff scientitst just opined that the data (a post hoc analysis) may be the result of detection bias. That is, it may well be an artifact. That is, since all study participants were given very thorough MRI exams at study end, it was much easier to track tumors in them. In the general population, a very different survivability picture may emerge. The tumors found (and reduced in size by Proscar) may well not matter a bit to how long a patient actually survives overall. [The JAMA published study data backs this notion pretty powerfully.]

~ He just said that 40 percent dropped out — most due to sexual side-effects.

~ He also opined that a major subgroup — one bearing the largest burden of the disease — African Americans — were “extremely underrepresented” in the data (4 percent, as opposed to 12 percent of the US population — underpowered by a factor of three).

. . . .Merck’s Proscar® and prostate cancer efficacy. . . .

[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. . . .

Be sure to read of the overnight JAMA-published developments, advocating a “wait and see” approach here, as opposed to such aggressive treatment for this largely non-life threatening condition.

Prescient Timing! Prostate Cancer Study Result, Today — Merck’s FDA Advisory Panel Tomorrow


MedPage Today is reporting on a JAMA study due out in the morning. This is essentially what I was pointing to yesterday — when I wrote that some doctors now believe a “wait and see” approach is better, for many types of prostate cancer. Let’s hope this learning is fully reflected in tomorrow’s FDA Advisory Committee meetings. We’ll have it here, either way, though — count on that.

A bit of the reporting runs thus — do go read it all:

. . . .Active surveillance for low-risk prostate cancer provides better quality of life than any immediate treatment, researchers found.

A hypothetical 65-year-old with newly diagnosed, clinically localized, low-risk prostate cancer would get at least an additional six months of quality-adjusted life expectancy from active surveillance compared with any treatment strategy with curative intent, according to a decision analysis published in the Dec. 1 issue of the Journal of the American Medical Association. . . .

The results were robust under a wide range of assumptions, even assuming a higher probability of prostate cancer death or progressive disease during active surveillance, Julia H. Hayes, MD, of the Dana-Farber Cancer Institute in Boston, and colleagues reported.

“This benefit reflects the deferred and substantially lower incidence of adverse effects of treatment experienced by men under active surveillance,” they wrote. . . .

Fascinating. We’ll have the streaming web-video feed of the FDA advisory panel’s meeting up here, in the morning. Do stop back.