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.

button coupons
button classifieds

In Other News...

Owensboro Innovation Academy to Open in Fall 2015

OWENSBORO, Ky. (11/22/14) — The Owensboro Public Schools are finalizing negotiations with the City of Owensboro to… Read More

Most Read This Week

November 21, 2014 5212

Man Accused of Assaulting Coach During Basketball…

in Local (Muhlenberg) Top News by Rita Dukes Smith, SurfKY News Director
November 18, 2014 5125

Couple Charged for Concealing Food in Infant Car…

in Local (Hopkins) Top News by Madisonville Police Department
November 17, 2014 4617

Police Charge Woman for Drug Possession After…

in Local (Hopkins) Top News by Madisonville Police Department
November 17, 2014 3803

Bremen Woman Ejected From Vehicle During Kentucky…

in Local (Muhlenberg) Top News by Trooper S.C. Recke
November 21, 2014 3189

Crashing Dump Trucks in Work Zone Cause Pennyrile…

in Top News For All Sites Touching Hopkins by Trooper Stu Recke
November 18, 2014 3115

Area Talent to Film Music Video at Merle Travis…

in Local (Muhlenberg) Top News by Paul McRee, SurfKY News
November 19, 2014 3051

Three Injured in Two-Vehicle Collision on South…

in Local (Hopkins) Top News by Gwen Smith
November 19, 2014 2848

Two Killed When Vehicle Becomes Airborne, Strikes…

in Local (Owensboro) Top News by Daviess County Sheriff's Office
November 21, 2014 2398

Muhlenberg District Court Fines Handed Down

in Local (Muhlenberg) Top News by Charles W. Riley II, SurfKY News
November 21, 2014 2239

Madisonville Police Arrest Reports - Nov. 21, 2014

in Hopkins News by Madisonville Police Department

Stories Trending Today

November 22, 2014 1497

One Injured in Two Vehicle Collion in Greenville

in Local (Muhlenberg) Top News by Miria Thomas
November 21, 2014 1157

KSP Announces 'Cram the Cruiser' to Feed the…

in Top News For All Sites Touching Hopkins by Stu Recke
November 22, 2014 1075

SAR Planning 'Triple' Revolutionary War Patriot…

in Local (Muhlenberg) Top News by Geoff Baggett
November 22, 2014 1055

Greenville Representatives Taking Part in Austin,…

in Local (Muhlenberg) Top News by Paul McRee, SurfKY News
November 21, 2014 1028

Kentucky Employers to Save About $112 million

in General News For All Sites by Cathy Lindsey
November 22, 2014 999

Carve a Turkey Like a Pro

in General News For All Sites by SurfKY News
November 22, 2014 966

Happenings and Meetings - Hopkins County

in Hopkins News by Amber Averitt, SurfKY News
November 22, 2014 901

Pennyrile Dulcimer Players Demonstrate Unique…

in Top News For All Sites by Ron Sanders
November 22, 2014 818

P'Pool Among Top Performing Child Support…

in Hopkins News by Cabinet for Health and Family Services
November 21, 2014 775

Kentucky State Parks Winter Holiday Events

in General News For All Sites by Gil Lawson

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