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 2015 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
button coupons

Stock Report

1 DOW 17,667.21
-5.39 (-0.03%)    
2 S&P 2,054.89
+3.07 (0.15%)    
3 NASDAQ 4,764.61
+6.73 (0.14%)    
3/13 - 16
3/13 - 16
button classifieds

In Other News...

MCCH Offers Free Screenings at the Love Your Heart Health Screening Event on Feb. 6

MURRAY, Ky. (1/25/15) — Murray-Calloway County Hospital encourages you to Love Your Heart in recognition of American… Read More

Juvenile Hit by Vehicle at McDonald's

GREENVILLE, Ky. (1/25/15) ― A juvenile was struck by a vehicle at the Greenville McDonald’s restaurant at 4:39 p.m.… Read More
3/13 - 16

Most Read This Week

January 23, 2015 8053

Local Church's Faith Restored; 71 Souls Saved…

in Video by Gary Gates, SurfKY News
January 20, 2015 6959

Bridal, Prom, Pageant Expo Planned for February…

in Hopkins News by Dana Brown
January 22, 2015 6915

Nortonville Man Accused of Selling Drugs near…

in Local (Hopkins) Top News by Madisonville Police Department/Hopkins County Jail
January 21, 2015 5575

KYDOT Pre-Treating Roads Thursday in Antipation…

in Top News For All Sites by Keith Todd
January 23, 2015 5520

Parents Face Charges after Marijuana Joint Falls…

in Local (Hopkins) Top News by Madisonville Police Department/Hopkins County Jail
January 22, 2015 5116

MCEA Head: Further School Mergers Might Ease…

in Local (Muhlenberg) Top News by Paul McRee, SurfKY News
January 21, 2015 4763

Man Arrested after Allegedly Nodding off on Baby…

in Local (Hopkins) Top News by Madisonville Police Department/Hopkins County Jail
January 23, 2015 4303

Nortonville Woman Charged for Meth Possession

in Local (Hopkins) Top News by Hopkins County Sheriff's Office/Hopkins County Detention Center
January 25, 2015 3694

Dean’s List Announced

in Top News For All Sites Touching Hopkins by Joyce Riggs
January 22, 2015 3614

Local Family Business Changes Hands

in Local (Hopkins) Top News by Doreen Dennis, SurfKY News

Stories Trending Today

January 25, 2015 3694

Dean’s List Announced

in Top News For All Sites Touching Hopkins by Joyce Riggs
January 25, 2015 1986

UPDATE: Two Die, Two Injured in Two-Vehicle…

in Local (Owensboro) Top News by Dispatcher Dustin Staves
January 25, 2015 1345

Juvenile Hit by Vehicle at McDonald's

in Local (Muhlenberg) Top News by GPD Officer Wes Miller
January 25, 2015 1210

Kynect Enrollment Climbs as Countdown to Feb. 15…

in General News For All Sites by Office of the Governor
January 25, 2015 1055

Market Commentary - Jan. 25, 2015

in Top News For All Sites by Randall L. Franklin
January 25, 2015 1022

Dave Says - Jan. 25, 2015

in General News For All Sites by Dave Ramsey
January 25, 2015 949

March 20-22 Women's Retreat: 'Holiness in Family…

in Owensboro News by Jennifer Kaminski
January 25, 2015 860

Outdoor Truths - Jan. 25, 2015

in General News For All Sites by Gary Miller
January 25, 2015 828

Legislator's Log - Week of Jan. 25, 2015

in General News For All Sites by Brent Yonts
January 26, 2015 513

Henderson County Traffic Advisory

in Local (Henderson) Top News by Keith Todd

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 © 2015 SurfKY News Group, Inc.  •  Terms of Use  •  Site Map

social fbsocial twsocial yt
social gpsocial flr subscribevideoitunessocial rss