Pick Your Community: | Hopkins | Muhlenberg | Daviess | Christian | Henderson | Lakes | McCracken | Webster

FDA Approves New Drug for Advanced Prostate Cancer

fda2WASHINGTON, D.C. (5/15/13) - The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.

Prostate cancer forms in a gland in the male reproductive system found below the bladder and in front of the rectum. The male sex hormone testosterone stimulates the prostate tumors to grow. According to the National Cancer Institute, an estimated 238,590 men will be diagnosed with prostate cancer and 29,720 will die from the disease in 2013.

Xofigo is being approved more than three months ahead of the product’s prescription drug user fee goal date of Aug. 14, 2013, the date the agency was scheduled to complete review of the drug application. The FDA reviewed Xofigo under the agency’s priority review program, which provides for an expedited review of drugs that appear to provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products.

“Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Xofigo is the second prostate cancer drug approved by the FDA in the past year that demonstrates an ability to extend the survival of men with metastatic prostate cancer.”

In August 2012, the FDA approved Xtandi to treat men with metastatic castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. Xtandi is approved for patients who have previously been treated the chemotherapy drug docetaxel.

Xofigo’s safety and effectiveness were evaluated in a single clinical trial of 809 men with symptomatic castration-resistant prostate cancer that spread to bones but not to other organs. Patients were randomly assigned to receive Xofigo or a placebo plus best standard of care.

The study was designed to measure overall survival. Results from a pre-planned interim analysis showed men receiving Xofigo lived a median of 14 months compared to a median of 11.2 months for men receiving placebo. An exploratory updated analysis conducted later in the trial confirmed Xofigo’s ability to extend overall survival.

The most common side effects reported during clinical trials in men receiving Xofigo were nausea, diarrhea, vomiting and swelling of the leg, ankle or foot. The most common abnormalities detected during blood testing included low levels of red blood cells (anemia), lymphocytes (lymphocytopenia), white blood cells (leukopenia), platelets (thrombocytopenia) and infection-fighting white blood cells (neutropenia).

Xofigo is marketed by Wayne, N.J.-based Bayer Pharmaceuticals. Xtandi is co-marketed by Astellas Pharma U.S., Inc. of Northbrook, Ill., and Medivation, Inc. of San Francisco, Calif.
 
SurfKY News
Information provided by the United States Food and Drug Administration

© Copyright 2014 SurfKY News Group, Inc. All rights reserved. This material may not be published, broadcast, or rewritten without permission. SurfKY News encourages you to share this story by using one of the social media links below.

In Other News...

Brescia University Named to Coveted Military Friendly Schools List

OWENSBORO, Ky. (10/1/14) — Victory Media Inc.'s Military Friendly Schools 2015 has recognized Brescia University among… Read More

Two Men Arrested on Multiple Drug Charges

OWENSBORO, Ky. (10/1/14) — Two people were arrested on multiple drug charges Tuesday, Sept. 30 on U.S. 60 Bypass near… Read More

Most Read This Week (Site-Wide)

September 29, 2014 3707

Endless Road Strings Bring Orchestra Mix to…

in Top Stories by Paul McRee, SurfKY News
October 01, 2014 3359

Muhlenberg Community Hospital to Host Lighting of…

in Top Stories by Information provided by Erin Warren
September 27, 2014 3193

Sinister on Center Takes Haunted Manor to Whole…

in Top Stories by Charles W. Riley II, SurfKY News
September 29, 2014 2635

One Injured in Single-Vehicle Collision on…

in Top Stories by Rita Dukes Smith, SurfKY News Director
September 28, 2014 2587

Community Shows Support to Muhlenberg Humane…

in Top Stories by Charles W. Riley II, SurfKY News
September 29, 2014 2526

Man, Woman Charged with Violating EPO Against…

in Top Stories by Madisonville Police Department
September 28, 2014 2324

Marching Mustangs Take Third in Ohio Competition

in Top Stories by Information provided by Shawna Hendrix
September 29, 2014 2213

Man Charged with PI, Drugs, After Allegedly…

in Top Stories by Madisonville Police Department
September 29, 2014 2091

Traffic Accident on Brown Road

in News by Madisonville Police Department
September 29, 2014 1835

Fourteen Year Old Parker Hastings Wins National…

in Top Stories by Paul McRee, SurfKY News
September 29, 2014 1678

One Injured in Two-Vehicle Collision

in Top Stories by Trooper Stu Recke

Most Read Stories from Hopkins County

September 29, 2014 2635

One Injured in Single-Vehicle Collision…

in Top Stories by Rita Dukes Smith, SurfKY News Director
September 29, 2014 2526

Man, Woman Charged with Violating EPO…

in Top Stories by Madisonville Police Department
September 29, 2014 2213

Man Charged with PI, Drugs, After…

in Top Stories by Madisonville Police Department
September 29, 2014 1658

Man Arrested for DUI, Marijuana Possession

in Top Stories by Madisonville Police Department
September 28, 2014 1458

Angel Garden Dedicated at Baptist…

in Top Stories by Tammy Holloway, SurfKY News

Most Read Stories from Muhlenberg County

September 29, 2014 3707

Endless Road Strings Bring Orchestra Mix…

in Top Stories by Paul McRee, SurfKY News
October 01, 2014 3359

Muhlenberg Community Hospital to Host…

in Top Stories by Information provided by Erin Warren
September 28, 2014 2587

Community Shows Support to Muhlenberg…

in Top Stories by Charles W. Riley II, SurfKY News
September 28, 2014 2324

Marching Mustangs Take Third in Ohio…

in Top Stories by Information provided by Shawna Hendrix
September 29, 2014 1835

Fourteen Year Old Parker Hastings Wins…

in Top Stories by Paul McRee, SurfKY News

SurfKY News Group, Inc. Central Office & Printing Division
1125 Nebo Rd.  •  Madisonville, KY 42431  •  270.452.2249 (fax)
Main Number: 270.452.2727 (phone)  •  Printing Division Direct Line: 270.821.8600 (phone)


Contact a member of our staff: www.surfky.com/contact
Copyright © 2014 SurfKY News Group, Inc.  •  Terms of Use  •  Site Map

social 03social 04social 22social 21social 06