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

LIKE SurfKY on Facebook - Click here to LIKE us now.

© Copyright 2015 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 on social media.

Posted on 2/2/14
3/13 - 16
3/13 - 16

Most Read This Week

April 17, 2015 11653

An Open Letter from an Addict

by Olivia Kirks
April 23, 2015 7246

Man Charged with Sodomy, Incest/Victim under 12

by SurfKY News
April 18, 2015 5722

Man Charged with Attempting to Coerce Minor for…

by Madisonville Police Department
April 20, 2015 4831

Nortonville Woman Charged with Meth Possession at…

by Madisonville Police Department
April 22, 2015 3969

Crime Stoppers Fugitive of the Week – April 22,…

by Hopkinsville – Christian County Crime Stoppers

Most Read This Month

April 17, 2015 11653

An Open Letter from an Addict

by Olivia Kirks
April 02, 2015 8778

UPDATE: Madisonville Man Injured in Head-on…

by Doreen Dennis, SurfKY News

Stories Trending Now

April 24, 2015 3785

UPDATE: Police Can't Substantiate Injured Man…

by Doreen Dennis, SurfKY News
April 23, 2015 758

Regional Eighth Grade Math Contest Held

by Joyce Riggs
April 24, 2015 755

Hopkins District Court Fines Handed Down

by Karen McKnight
April 24, 2015 739

Madisonville Police Arrest Reports Released -…

by SurfKY News
April 24, 2015 683

Probation and Parole Violators - April 24, 2015

by Gary Gates, SurfKY News
April 24, 2015 628

Baptist Health Holds ‘Walk in the Park’ as Part…

by Tammy Holloway, SurfKY News
April 24, 2015 608

Career Fair Provides Students Information about…

by Tammy Holloway, SurfKY News
April 24, 2015 587

Hopkins County Sheriff's Reports Released

by SurfKY News
April 24, 2015 584

Muhlenberg District Court Fines Handed Down

by Charles W. Riley II, SurfKY News
April 24, 2015 481

KSP Charges Franklin County Man with…

by SurfKY News