Find Information About:

Drugs & Supplements

Get information and reviews on prescription drugs, over-the-counter medications, vitamins, and supplements. Search by name or medical condition.

Pill Identifier

Pill Identifier

Having trouble identifying your pills?

Enter the shape, color, or imprint of your prescription or OTC drug. Our pill identification tool will display pictures that you can compare to your pill.

Get Started

My Medicine

Save your medicine, check interactions, sign up for FDA alerts, create family profiles and more.

Get Started

WebMD Health Experts and Community

Talk to health experts and other people like you in WebMD's Communities. It's a safe forum where you can create or participate in support groups and discussions about health topics that interest you.

  • Second Opinion

    Second Opinion

    Read expert perspectives on popular health topics.

  • Community


    Connect with people like you, and get expert guidance on living a healthy life.

Got a health question? Get answers provided by leading organizations, doctors, and experts.

Get Answers

Sign up to receive WebMD's award-winning content delivered to your inbox.

Sign Up

Font Size

FDA Approves Prostate Cancer Drug

Zytiga Fights Treatment-Resistant Prostate Cancer
WebMD Health News
Reviewed by Laura J. Martin, MD

April 28, 2011 -- The FDA has approved the Johnson & Johnson pill Zytiga for use in combination with the steroid prednisone to treat a certain type of late-stage prostate cancer in men who have already been treated with chemotherapy.

The medication is to be used to treat patients with metastatic, castration-resistant prostate cancer.

In men with prostate cancer, the male sex hormone testosterone stimulates the tumor to grow.

The FDA says in a statement that drugs or surgery are used to reduce testosterone production or block the effects of testosterone, but that prostate cancer sometimes continues to grow, even when testosterone levels are low. Men with such cancers are said to have castration-resistant prostate cancer.

What Zytiga Does

Zytiga (abiraterone acetate) targets a protein called CYP17A1, which the FDA says plays a key role in the production of testosterone.

The agency says the drug works by decreasing the production of testosterone that stimulates cancer cells to keep growing.

The application for approval of the pill, made by the Johnson & Johnson unit Centocor Ortho Biotech, was considered under the FDA’s priority review process. The FDA says that process provides for an expedited six-month review for drugs that are believed to offer major advances in treatment or which provide a treatment when no adequate therapy exists.

Zytiga Prolongs Life

“Zytiga prolonged the lives of men with late-stage prostate cancer who had received prior treatments and had few available therapeutic options,” Richard Pazdur, MD, director of the FDA’s Office of Oncology Drug Products, says in the agency’s news release.

The FDA says the drug’s safety and effectiveness were established in a clinical study involving 1,195 patients with late-stage castration-resistant prostate cancer who had received treatment with docetaxel chemotherapy.

Patients in the study received either Zytiga once daily in combination with prednisone two times per day, or a placebo twice daily in combination with prednisone.

Patients who received the Zytiga and prednisone combo had a median overall survival of 14.8 months, compared to 10.9 months for those in the group taking the placebo-prednisone combination.

Today on WebMD

man with doctor
Symptoms, risks, treatments
man coughing
Men shouldn’t ignore
prostate cancer cells
What does this diagnosis mean?
doctor and male patient
Is it worth it?
cancer fighting foods
15 Cancer Symptoms Men Ignore
Prostate Enlarged
Picture Of The Prostate
Prostate Cancer Quiz
screening tests for men
Prostate Cancer Symptoms
Vitamin D