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.

Posted on 2/2/14
Genovese - http://www.mchky.org/staff/bio.php?doc_id=35646&sub= Lewis - http://www.mchky.org/getpage.php?name=bracken_lewis Holt - http://www.mchky.org/getpage.php?name=drholt Napier - http://www.mchky.org/getpage.php?name=dr.napier_page Newman - http://www.mchky.org/staff/bio.php?doc_id=50353
Genovese - http://www.mchky.org/staff/bio.php?doc_id=35646&sub= Lewis - http://www.mchky.org/getpage.php?name=bracken_lewis Holt - http://www.mchky.org/getpage.php?name=drholt Napier - http://www.mchky.org/getpage.php?name=dr.napier_page Newman - http://www.mchky.org/staff/bio.php?doc_id=50353
2/6/2014 - posted

Stock Report

1 DOW 17,156.53
+24.56 (0.14%)    
2 S&P 2,002.95
+3.97 (0.20%)    
3 NASDAQ 4,562.08
+9.32 (0.20%)    
Genovese - http://www.mchky.org/staff/bio.php?doc_id=35646&sub= Lewis - http://www.mchky.org/getpage.php?name=bracken_lewis Holt - http://www.mchky.org/getpage.php?name=drholt Napier - http://www.mchky.org/getpage.php?name=dr.napier_page Newman - http://www.mchky.org/staff/bio.php?doc_id=50353
Genovese - http://www.mchky.org/staff/bio.php?doc_id=35646&sub= Lewis - http://www.mchky.org/getpage.php?name=bracken_lewis Holt - http://www.mchky.org/getpage.php?name=drholt Napier - http://www.mchky.org/getpage.php?name=dr.napier_page Newman - http://www.mchky.org/staff/bio.php?doc_id=50353
2/6/2014 - posted
Genovese - http://www.mchky.org/staff/bio.php?doc_id=35646&sub= Lewis - http://www.mchky.org/getpage.php?name=bracken_lewis Holt - http://www.mchky.org/getpage.php?name=drholt Napier - http://www.mchky.org/getpage.php?name=dr.napier_page Newman - http://www.mchky.org/staff/bio.php?doc_id=50353
Genovese - http://www.mchky.org/staff/bio.php?doc_id=35646&sub= Lewis - http://www.mchky.org/getpage.php?name=bracken_lewis Holt - http://www.mchky.org/getpage.php?name=drholt Napier - http://www.mchky.org/getpage.php?name=dr.napier_page Newman - http://www.mchky.org/staff/bio.php?doc_id=50353
2/6/2014 - posted

In Other News...

Hopkins County Sheriff's Arrest Reports

HOPKINS COUNTY, Ky. (9/16/14) — The Hopkins County Sheriff's Office recently released the following arrest reports.… Read More

Upcoming Coffeehouse Show

HOPKINS COUNTY, Ky. (9/16/14) — Appalachian Pop is often used to describe the inviting sounds of Count This Penny.… Read More
Genovese - http://www.mchky.org/staff/bio.php?doc_id=35646&sub= Lewis - http://www.mchky.org/getpage.php?name=bracken_lewis Holt - http://www.mchky.org/getpage.php?name=drholt Napier - http://www.mchky.org/getpage.php?name=dr.napier_page Newman - http://www.mchky.org/staff/bio.php?doc_id=50353
Genovese - http://www.mchky.org/staff/bio.php?doc_id=35646&sub= Lewis - http://www.mchky.org/getpage.php?name=bracken_lewis Holt - http://www.mchky.org/getpage.php?name=drholt Napier - http://www.mchky.org/getpage.php?name=dr.napier_page Newman - http://www.mchky.org/staff/bio.php?doc_id=50353
2/6/2014 - posted

Most Read This Week (Site-Wide)

September 15, 2014 4025

Man Accused of Stalking Woman During Her…

in Top Stories by GPD PIO Wes Miller
September 15, 2014 4008

Man Accused of Stealing Rural King…

in Top Stories by MCSO PIO Alex Piper
September 13, 2014 3743

MPD Responds to a Disturbance at Baptist…

in Top Stories by Madisonville Police Department
September 16, 2014 2442

Postal Worker Arrested for Terroristic…

in Top Stories by GPD PIO Wes Miller
September 15, 2014 2062

Man Arrested for DUI, Carrying Concealed…

in Top Stories by Madisonville Police Department

Most Read Stories from Hopkins County

September 13, 2014 3743

MPD Responds to a Disturbance at Baptist…

in Top Stories by Madisonville Police Department
September 15, 2014 2062

Man Arrested for DUI, Carrying Concealed…

in Top Stories by Madisonville Police Department
September 15, 2014 1957

Man Arrested for Being Under Influence of…

in Top Stories by Madisonville Police Department
September 13, 2014 445

Quilt Exhibit Reception Sept. 14

in Top Stories by Chris Wilson
September 16, 2014 428

Dawson Springs Police Chief to Retire on…

in Top Stories by Amber Averitt, SurfKY News

Most Read Stories from Owensboro

September 13, 2014 1363

The Gift of Aging Oct. 16

in News by Jennifer Kaminski
September 13, 2014 1326

Audubon Bon Harbor Area Alliance to Host…

in News by Abby Shelton
September 13, 2014 1316

Dogwood Azalea Neighborhood Alliance to…

in News by Abby Shelton
September 13, 2014 936

Wesleyan Shawnee Neighborhood Alliance to…

in News by Abby Shelton
September 13, 2014 588

US 60 Extension at Owensboro to Open…

in Top Stories by Keith Todd

Most Read Stories from Muhlenberg County

September 15, 2014 4025

Man Accused of Stalking Woman During Her…

in Top Stories by GPD PIO Wes Miller
September 15, 2014 4008

Man Accused of Stealing Rural King…

in Top Stories by MCSO PIO Alex Piper
September 16, 2014 2442

Postal Worker Arrested for Terroristic…

in Top Stories by GPD PIO Wes Miller
September 14, 2014 1574

Three Injured in Single-Car Collision

in Top Stories by Robert LIttlepage
September 13, 2014 1317

Local Author Signs Copies of Her New Book

in Top Stories by Charles W. Riley II, SurfKY News

SurfKY News Group, Inc. Central Office & Printing Division
1125 Nebo Rd.  •  Madisonville, KY 42431  •  270.452.2249 (fax)
Main Number: 270.452.2727 (phone)  •  Printing Division Direct Line: 270.821.8600 (phone)


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

social 03social 04social 22social 21social 06