Pick Your Community: | Hopkins | Muhlenberg | Daviess | Christian | Henderson | Lakes | McCracken | Webster
Impressions pre-reset: 420826 Clicks pre-reset: 872

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.

3/13 - 16
3/13 - 16
button coupons

Stock Report

1 DOW 17,827.75
+12.81 (0.07%)    
2 S&P 2,072.83
+5.80 (0.28%)    
3 NASDAQ 4,787.32
+29.06 (0.61%)    
3/13 - 16
3/13 - 16
button classifieds

In Other News...

Muhlenberg Set for Small Business Saturday Savings

MUHLENBERG COUNTY, Ky. (11/26/14) — Think small, save big. That's the message this holiday season from the Greater… Read More

Civil War Comes to The Homeplace

GOLDEN POND, Ky. (11/27/14) — Land Between The Lakes National Recreation Area presents Civil War Comes to The… Read More
3/13 - 16

Most Read This Week

November 21, 2014 7216

Man Accused of Assaulting Coach During Basketball…

in Local (Muhlenberg) Top News by Rita Dukes Smith, SurfKY News Director
November 22, 2014 4886

One Injured in Two Vehicle Collision in Greenville

in Local (Muhlenberg) Top News by Miria Thomas
November 21, 2014 4576

Crashing Dump Trucks in Work Zone Cause Pennyrile…

in Top News For All Sites Touching Hopkins by Trooper Stu Recke
November 21, 2014 3814

Muhlenberg District Court Fines Handed Down

in Local (Muhlenberg) Top News by Charles W. Riley II, SurfKY News
November 21, 2014 3622

Madisonville Police Arrest Reports - Nov. 21, 2014

in Hopkins News by Madisonville Police Department
November 21, 2014 3178

Swimming and Diving Closes Fall Season at Ohio…

in General Sports For All Sites by UK Athletics
November 24, 2014 3024

Two Charged for Possession of Meth After…

in Local (Muhlenberg) Top News by MCSO/PIO Alex Piper
November 21, 2014 2890

Kentucky Employers to Save About $112 million

in General News For All Sites by Cathy Lindsey
November 25, 2014 2632

Madisonville Man Charged for Selling Cocaine

in Local (Hopkins) Top News by Madisonville Police Department
November 25, 2014 2508

Call for Help Results in Arrest for Possession of…

in Local (Hopkins) Top News by Madisonville Police Department

Stories Trending Today

November 25, 2014 1612

Protect Your Home When Traveling This Holiday…

in General News For All Sites by SurfKY News
November 26, 2014 1161

Baptist Health Madisonville Hires New Physical…

in Local (Hopkins) Top News by Kristy Quinn
November 26, 2014 1076

Madisonville Police Arrest Reports - Nov. 26, 2014

in Hopkins News by Madisonville Police Department
November 26, 2014 1067

Sweet Staple of Thanksgiving

in General News For All Sites by SurfKY News
November 26, 2014 958

Muhlenberg Set for Small Business Saturday Savings

in Local (Muhlenberg) Top News by Paul McRee, SurfKY News
November 26, 2014 804

Citizen Sounds Off About Library

in Hopkins News by Scott Rogers
November 26, 2014 771

High School Wrestling Teams Returning to…

in General Sports For All Sites by Steve LeMaster
November 26, 2014 738

Madisonville Man Charged with Selling Cocaine

in Local (Hopkins) Top News by Lt. William W. Poe
November 26, 2014 724

UK Volleyball Finalizes 2015 Class with Watson

in General Sports For All Sites by UK Athletics
November 26, 2014 629

Crime Stoppers Top Most Wanted - November 26, 2014

in Video by Crime Stoppers

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