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.

Started 11/8/2013
Started 11/8/2013
Started 11/8/2013
Started 11/8/2013
Started 11/8/2013
Started 11/8/2013

In Other News...

UPDATE: Missing Elderly Couple Found

UPDATE: DAWSON SPRINGS, Ky. (10/30/14) ― The Frosts have been located safe and sound in Louisville, according to the… Read More

Emergency Off Load of Burning Trash Extinguished on Noel Avenue

MADISONVILLE, Ky. (10/29/14) — A quick-thinking Madisonville City Sanitation truck driver dumped the load of trash he… Read More
Started 11/8/2013
Started 11/8/2013

Most Read This Week

October 29, 2014 8686

UPDATE: Medical Examiner's Official Report…

in Local (Lakes) Top News by Dennis Thomas
October 24, 2014 7421

Central City Man Charged with Sexual Assault on…

in Local (Muhlenberg) Top News by Chris Cooper
October 27, 2014 5993

Earlington Woman Charged With Burglary for…

in Local (Hopkins) Top News by Madisonville Police Department
October 23, 2014 4364

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

in Top News For All Sites by Paul McRee, SurfKY News
October 27, 2014 4291

Baptist Health Madisonville Performs Baptist…

in Local (Hopkins) Top News by Kristy Quinn
October 28, 2014 3851

UPDATE: 'Runner' Ran Home; Family Happy

in Hopkins News by Lisa Crook
October 24, 2014 3737

Miners Turn Out in Madisonville for…

in Top News For All Sites by Rita Dukes Smith, SurfKY News Director
October 29, 2014 3726

UPDATE: Two More Arrested for Meth at Area Motel

in Local (Hopkins) Top News by Trooper Stu Recke
October 27, 2014 3265

Woman Charged for Domestic Assault with Scissors,…

in Local (Hopkins) Top News by Madisonville Police Department
October 28, 2014 3218

UPDATE: Extended to Wednesday; Heaven's Gates and…

in Local (Muhlenberg) Top News by Paul McRee, SurfKY News

Stories Trending Today

October 29, 2014 8686

UPDATE: Medical Examiner's Official Report…

in Local (Lakes) Top News by Dennis Thomas
October 29, 2014 3726

UPDATE: Two More Arrested for Meth at Area Motel

in Local (Hopkins) Top News by Trooper Stu Recke
October 29, 2014 2394

Hypodermic Needle Sticking Out of Jacket During…

in Local (Hopkins) Top News by Madisonville Police Department
October 29, 2014 2074

Pennyrile Gymnastic Team to Perform on 'America's…

in Local (Hopkins) Top News by Paul McRee, SurfKY News
October 29, 2014 1703

Madisonville Police Arrest Reports - Oct. 29, 2014

in Hopkins News by Madisonville Police Department
October 29, 2014 1659

Huge Crowds Visit Uncle Lee’s First Day of…

in Local (Muhlenberg) Top News by Charles W. Riley II, SurfKY News
October 29, 2014 1387

Trespassing Complaint Ends with Shoplifting Arrest

in Hopkins News by Madisonville Police Department
October 29, 2014 1144

Water Main Break Sends Stream Dozens of Feet in…

in Hopkins News by Rita Dukes Smith, SurfKY News Director
October 30, 2014 1129

UPDATE: Missing Elderly Couple Found

in Local (Hopkins) Top News by Chief William C. Crider
October 29, 2014 992

Greenwood Indicted by Logan County Grand Jury

in Local (Muhlenberg) Top News by Charles W. Riley II, 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