Pick Your Community: | Hopkins | Muhlenberg | Daviess | Christian | Henderson | Lakes | McCracken | Webster
Davis Motor Sales banner ad

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...

High-Traction, Anti-Skid Coating Application Nearing Completion

MARSHALL COUNTY, Ky. (10/24/14) — A contractor for the Kentucky Transportation Cabinet is nearing completion on a… Read More

UPDATE: Cadiz Police Investigating Bank Robbery

CADIZ, Ky. (10/24/14) — The Cadiz Police Department has issued a warrant for the arrest of Donald Cardale Bacon II, 19,… Read More

Most Read This Week

October 20, 2014 7336

Uncle Lee's in Greenville is Closing Its Doors…

in Local (Muhlenberg) Top News by www.unclelees.com
October 19, 2014 4958

Kentucky Energy Department Releases Virtual Solar…

in General News For All Sites by Dick Brown
October 21, 2014 3552

UPDATE: Pedestrian Struck by Vehicle on Shamrock…

in Local (Hopkins) Top News by Officer C.P. Haynie
October 22, 2014 3272

Hopkins County Grand Jury Indictments

in Hopkins News by Karen McKnight
October 21, 2014 3149

Madisonville Police Arrest Reports - Oct. 21, 2014

in Hopkins News by Madisonville Police Department
October 23, 2014 3050

Resident Returns Home to People Using Drugs,…

in Local (Hopkins) Top News by Madisonville Police Department
October 20, 2014 2951

Man Charged for Assaulting Pregnant Wife

in Local (Hopkins) Top News by Madisonville Police Department
October 20, 2014 2944

Hopkins County Sheriff's Arrest Reports Released

in Hopkins News by Sheila Hopper
October 22, 2014 2601

Convicted Felon Charged for Handgun Possession…

in Local (Muhlenberg) Top News by Trooper Stu Recke
October 20, 2014 2447

Paul Simon Headlines COPD Tribute for Phil Everly

in Top News For All Sites by Paul McRee, SurfKY News

Stories Trending Today

October 24, 2014 2205

Central City Man Charged with Sexual Assault on…

in Local (Muhlenberg) Top News by Chris Cooper
October 23, 2014 1919

Don Everly to be Part of Rock and Roll Hall of…

in Top News For All Sites by Paul McRee, SurfKY News
October 24, 2014 1869

Miners Turn Out in Madisonville for…

in Top News For All Sites by Rita Dukes Smith, SurfKY News Director
October 24, 2014 1810

Woman Arrested for Allegedly Reporting Check…

in Local (Hopkins) Top News by Madisonville Police Department
October 24, 2014 1624

Madisonville Police Arrest Reports - Oct. 24, 2014

in Hopkins News by Madisonville Police Department
October 24, 2014 1509

Family Looking for 'Runner'

in Hopkins News by Lisa Crook
October 24, 2014 1395

County Renews Career Advancement Lease

in Local (Muhlenberg) Top News by Charles W. Riley II, SurfKY News
October 24, 2014 1354

Baldwin, Crist and Saint Selected to 2014 Second…

in Hopkins Sports by Troy Crist
October 24, 2014 1281

Tail Light Out Traffic Stop Turns to Drug Arrest

in Local (Hopkins) Top News by Madisonville Police Department
October 23, 2014 975

Security Officer Offers Identity Theft Protection…

in Local (Hopkins) Top News by Amber Averitt, SurfKY News

SurfKY News Group, Inc.
Corporate Office & Studio
1125 Nebo Rd.  •  Madisonville, KY 42431
270.452.2727 (phone)
  •  270.452.2249 (fax)


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

social fbsocial twsocial yt
social gpsocial flrsocial rss