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:12/7/2016)... ... December 07, 2016 , ... "Today, MHA ... most comprehensive mental health systems reform legislation in more than fifty years. We ... the commitment of our elected officials to improving mental health services and supports ...
(Date:12/7/2016)... ... December 07, 2016 , ... Silhouette Instalift is a simple, ... and tightening the skin of the face to create more youthful features. While ... very little downtime, Silhouette Instalift is a novel, minimally invasive facial procedure that ...
(Date:12/7/2016)... ... December 07, 2016 , ... ... a purchase price of approximately $17.4 million (net of the cash acquired), ... approximately $13.2 million. Headquartered in Barcelona, Spain, Presence is a leading provider ...
(Date:12/7/2016)... Valley, CA (PRWEB) , ... December 07, 2016 , ... ... be used in several ways to restore a more youthful appearance to the face. ... now offer Sculptra, along with a variety of other treatments, to rejuvenate and renew ...
(Date:12/7/2016)... , ... December 07, 2016 , ... They are musicians ... sisters and wives, brothers and fathers, from New England and around the nation. What ... stigma, and are brought together in a beautiful and compelling new photographic exhibit debuting ...
Breaking Medicine News(10 mins):
(Date:12/8/2016)... , Dec. 8, 2016 Henry Schein, Inc. ... health care products and services to office-based dental, animal health ... percent equity investment in Marrodent, one of Poland,s ... approximately $32 million. This transaction was announced on August 30, ... in Poland since 2014, and Marrodent ...
(Date:12/8/2016)... Research and Markets has announced the addition of ... their offering. ... The report provides separate comprehensive analytics for the ... Rest of World. Annual estimates and forecasts are provided ... provided for these markets. Market data and analytics are derived from primary ...
(Date:12/7/2016)... , Dec. 7, 2016 "Lantus (Insulin Glargine) Biosimilar Clinical ... on 37 biosimilar version of Lantus drug in clinical pipeline. Currently 5 ... , Japan , Kenya , ... Germany , China , Slovakia ... 1 & 2 diabetes mellitus. The patent on Lantus expired in 2014. ...
Breaking Medicine Technology: