Navigation Links
FDA Panel to Vote on Drugs to Prevent Prostate Cancer
Date:12/1/2010

WEDNESDAY, Dec. 1 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel is expected to decide Wednesday whether to approve two drugs for the prevention of prostate cancer, the third highest cancer killer of men.

Avodart and Proscar, manufactured by GlaxoSmithKline and Merck, respectively, are already approved to treat enlarged prostates. The drug makers say their research shows the drugs also lower the risk of prostate cancer by more than 20 percent.

FDA regulators have several concerns, the Associated Press reported. For one thing, black men, who are at high risk for the disease, were underrepresented in the clinical trials. "The applicability to African-American men is not known due to marked under-representation," the FDA's online review stated.

Blacks made up just 4 percent of Merck's patients and only 2 percent of Glaxo's patients, according to the AP.

The panel of outside experts assembled by the FDA is also likely to discuss the overall value of preventing low-grade tumors. According to the FDA, more than three-quarters of the tumors the drugs prevent are slow-growing, meaning they are non-aggressive and probably not life-threatening for anyone with a life expectancy of less than 20 years.

But even if the tumors aren't aggressive, Glaxo has said they often involve unnecessary treatment and biopsies, or surgical procedures, to diagnose cancer, that pose risks of their own.

Also, slightly more aggressive tumors were seen in men taking Avodart and Proscar, compared with those taking placebo pills, according to the FDA. But the pharamaceutical companies say the drugs simply make those tumors easier to detect because they shrink the prostate.

The U.S. National Cancer Institute estimates that 217,730 men will be diagnosed with prostate cancer this year and 32,050 men will die of it.

The FDA usually follows the recommendations of its expert panels, although it is not required to do so. If given the go-ahead, Avodart and Proscar would be the first drugs to win FDA approval for prevention of prostate cancer.

More information

For more on prostate cancer, visit the U.S. National Library of Medicine.

-- Margaret Steele

SOURCES: U.S. Food and Drug Administration; Associated Press


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Medicare Panel Endorses Vaccine for Prostate Cancer Patients
2. Teens Should Get Meningitis Booster Shot: CDC Panel
3. Expert Panel Links Popular Bone Drugs to Rare Fracture
4. FDA Panel to Mull Ban on Diet Drug Meridia
5. Experts Support FDA Panels Backing of New Blood Thinner
6. Avandia Raises Heart Risk But Should Stay on Market, FDA Panel Finds
7. FDA Panel Seems Skeptical Over Key Avandia Data
8. FDA Panel Appears Skeptical Over Key Avandia Data
9. NJIT professor heads panel studying sudden car acceleration
10. FDA Panel Votes Against Approval of Female Viagra
11. FDA Panel Weighs OK of Female Viagra
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... ... temporary closing of Bruton Memorial Library on June 21 due to a possible lice infestation, ... aspect of head lice: the parasite’s ability to live away from a human host, and ... necessary one in the event that lice have simply gotten out of control. , As ...
(Date:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding ... of its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. ... James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. ...
(Date:6/25/2016)... ... 25, 2016 , ... Dr. Calvin Johnson has dedicated his ... implemented orthobiologic procedures as a method for treating his patients. The procedure is ... to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use to help ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits ... terms of the latter, setting the bar too high can result in disappointment, perhaps ... slow progress toward their goal. , Research from PsychTests.com reveals that ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Those who ... with these feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, ... Marne, Michigan, has released tools for healthy coping following a traumatic event. , Trauma ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016 ... Markets has announced the addition of the " ... offering. This ... and provides an updated review, including its applications in ... the total market, which includes three main industries: pharmaceutical ...
(Date:6/24/2016)... 24, 2016 Research and Markets has ... Companion Diagnostic Tests" report to their offering. ... Diagnostics The World Market for Companion Diagnostics ... diagnostics. Market analysis in the report includes the following: ... Vitro Diagnostic Kits) by Region (N. America, EU, ROW), 2015-2020 ...
(Date:6/23/2016)... , June 23, 2016  MedSource announced today ... its e-clinical software solution of choice.  This latest ... possible value to their clients by offering a ... preferred relationship establishes nowEDC as the EDC platform ... MedSource,s full-service clients.  "nowEDC has long been a ...
Breaking Medicine Technology: