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:10/13/2017)... ... October 13, 2017 , ... ProVest Insurance Group, a family ... and Raleigh regions, is organizing an extended charity drive to benefit the family ... abnormality. , After struggling since birth with several health challenges, T.J. was later ...
(Date:10/13/2017)... ... October 13, 2017 , ... The International Association of Eating ... excellence for the field of eating disorders, announces the opening of early registration ... Orlando, Florida at the Omni Resort at ChampionsGate. , The annual ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Many families have ... many long-term care insurance companies have a waiver for care if the client has ... period, when the family pays for care, is often waived, so the benefits from ...
(Date:10/13/2017)... , ... October 13, 2017 , ... ... be giving viewers the lowdown on sciatica in a new episode of "Success ... focuses on current events and innovation and investigates each subject in-depth with passion ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and ... apnea using cutting-edge Oventus O2Vent technology. As many as 18 million Americans ... frequent cessation in breathing. Oral appliances can offer significant relief to about 75 ...
Breaking Medicine News(10 mins):
(Date:9/25/2017)... Sept. 25, 2017  EpiVax, Inc., a leader ... and immune-engineering today announced the launch of EpiVax ... of personalized therapeutic cancer vaccines. EpiVax has provided ... access to enabling technologies to the new precision ... lead EpiVax Oncology as Chief Executive Officer. Gad ...
(Date:9/19/2017)... Ky. , Sept. 19, 2017   ZirMed Inc ... predictive analytics, today announced that it has been ranked #1 ... Black Book™ Rankings 2017 User Survey. ZirMed was ... solution for large hospitals and medical centers over 200 beds ... Black Book,s healthcare technology user survey history. ...
(Date:9/12/2017)... LAKES, N.J. , Sept. 12, 2017  Consumer reviews on ... Embrace Hearing as the number one company for hearing aids, ... ReSound™ and fifteen other brands. ... Embrace Hearing Named #1 by Consumers For Hearing Aids ... Embrace Hearing is an online store that provides ...
Breaking Medicine Technology: