Navigation Links
FDA OKs Expanded Use of Prostate Cancer Drug
Date:12/10/2012

MONDAY, Dec. 10 (HealthDay News) -- The approved use of the drug Zytiga has been expanded to include treatment of men with late-stage, hormone therapy-resistant prostate cancer before they undergo chemotherapy, the U.S. Food and Drug Administration announced Monday.

Zytiga was initially approved in April 2011 for treatment of prostate cancer patients whose disease had progressed after treatment with the chemotherapy drug docetaxel.

The drug decreases production of the male sex hormone testosterone. In prostate cancer, testosterone stimulates prostate tumors to grow. Drugs or surgery are used to reduce testosterone production or to block the hormone's effects.

However, some men have what's called "castration-resistant" or hormone therapy-resistant prostate cancer, which means that prostate cancer cells continue to grow even with low levels of testosterone, the FDA explained in a news release.

The expanded approval is based on a study of 1,088 men with late-stage, hormone therapy-resistant prostate cancer who took either Zytiga (abiraterone acetate) or an inactive placebo in combination with another drug called prednisone.

Median overall survival was just over 35 months for patients who took Zytiga and about 30 months for those who took the placebo, the FDA noted.

The most common side effects among patients taking Zytiga included fatigue, joint discomfort, swelling caused by fluid retention, hot flush, diarrhea, vomiting, cough, high blood pressure, shortness of breath, urinary tract infection and bruising.

This expanded approval of Zytiga was made under the FDA's priority review program, which offers an accelerated six-month review for drugs that may offer major advances in treatment or provide a treatment when no adequate therapy exists.

"Today's approval demonstrates the benefit of further evaluating a drug in an earlier disease setting and provides patients and health care providers the option of using Zytiga earlier in the course of treatment," Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research, said in the FDA news release.

Zytiga is marketed by Pennsylvania-based Janssen Biotech Inc.

More information

The American Cancer Society has more about prostate cancer.

-- Robert Preidt

SOURCE: U.S. Food and Drug Administration, news release, Dec. 10, 2012


'/>"/>
Copyright©2012 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Prostate cancer now detectable by imaging-guided biopsy
2. Targeted prostate biopsy has potential to improve diagnosis of prostate cancer
3. The Project for Natural Health Choices Inc. Issues an Advisory for Men to Consume Flavonoids in their Diet to Protect Against Prostate Cancer
4. Targeted Prostate Cancer Biopsies Might Improve Care: Study
5. Longer life expectancy, aging population necessitate new strategies for prostate cancer care
6. Drug shows promise in prostate cancer spread to bone
7. Clinical trial at GHSU Cancer Center targets advanced prostate cancer
8. COUP-TFII sparks prostate cancer progression
9. UAlberta prostate cancer researcher and team developing homing beacon drugs to target cancer cells
10. Prostate Cancer Websites Often Hard to Understand: Study
11. Mayo Clinic gets FDA approval for new imaging agent for recurrent prostate cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/19/2017)... ... 2017 , ... Orbita, Inc., a leading provider ... Healthwise ® at HIMSS 2017 to showcase a breakthrough in remote ... technology and services, will demonstrate a voice-powered knowedge assistant based on Orbita ...
(Date:2/18/2017)... , ... February 17, 2017 , ... ... source of disruptive innovation in the industry, according to the recent NEJM Catalyst ... based on surveys of the NEJM Catalyst Insights Council, a qualified group of ...
(Date:2/18/2017)... Beverly Hills, California (PRWEB) , ... February 17, ... ... 273-3007, info@drvallecillos.com , drvallecillos.com , Beverly Hills plastic surgeon ... reduce subcutaneous fat cells. , Dr. Vallecillos says, "Traditionally, plastic surgery has been ...
(Date:2/18/2017)... ... February 18, 2017 , ... ProParagraph Fashion Volume 2 features ... ProParagraph Fashion Volume 2 for all multi-line FCPX project needs. Great for ... and choose from hand-crafted trend-setting designs with smooth animations that will add stylistic ...
(Date:2/17/2017)... ... ... Smiles by Seese is a comprehensive family dental practice located ... practice as a skilled and highly credentialed dentist who is qualified to perform a ... all ages with excellence in general, restorative, and cosmetic dentistry . Their services ...
Breaking Medicine News(10 mins):
(Date:2/17/2017)... 17, 2017 On Thursday, February ... edged lower at the closing bell, while the Dow ... 20,000 benchmark. Moreover, five out of nine sectors ended ... yesterday,s market sentiment, Stock-Callers.com assessed the following Medical Appliances ... (NYSE: SNN ), ABIOMED Inc. (NASDAQ: ...
(Date:2/16/2017)... Quest Diagnostics (NYSE: DGX ), ... announced that it has been named one of the ... The annual survey designated Quest Diagnostics as ... Pharmacy and Other Services" industry to attain Most Admired ... attain the designation. This is the second consecutive year ...
(Date:2/16/2017)... Conn. , Feb. 16, 2017 The Lockwood ... the 2017 Best Place to Work in Connecticut ... This is the third year in a row that Lockwood ... this year to earn the number-two spot in 2017. The ... maintaining workplace excellence. The winners were determined through a survey ...
Breaking Medicine Technology: