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...

January Events at Maple Mount

OWENSBORO, Ky. (12/16/14) — The following events are scheduled for January: Ursuline presentation "See as the Mystics… Read More

'Cram the Cruiser' Concludes with Great Success

OWENSBORO, Ky. (12/17/14) — Cram the Cruiser concluded Dec. 16, 2014 and Post 16 has received the largest amount of… Read More

Most Read This Week

December 16, 2014 8128

Coal Miner Fatally Injured in Underground Mining…

in Top News For All Sites by Dick Brown
December 14, 2014 8042

Muhlenberg Pays Homage to U.S. Armed Forces

in Local (Muhlenberg) Top News by Charles W. Riley II, SurfKY News
December 12, 2014 7578

Man Allegedly Threatening Medical Staff with…

in Local (Muhlenberg) Top News by Wes Miller
December 15, 2014 4499

Hopkins County Woman Charged Second Time in Two…

in Local (Hopkins) Top News by Charles W. Riley II, SurfKY News
December 11, 2014 4487

Muhlenberg District Court Fines Handed Down

in Local (Muhlenberg) Top News by Charles W. Riley II, SurfKY News
December 12, 2014 4301

Man Allegedly Hits Brother with Pickup Truck…

in Local (Muhlenberg) Top News by Wesley Miller
December 15, 2014 4131

Woman Leads Police on High-Speed Chase in Stolen…

in Local (Hopkins) Top News by Madisonville Police
December 11, 2014 4008

Madisonville Police Arrest Reports - Dec. 11, 2014

in Hopkins News by Madisonville Police Department
December 12, 2014 3699

Man Accused of Public Intoxication, Stealing…

in Local (Hopkins) Top News by Madisonville Police Department
December 15, 2014 3099

Vehicle Careens down 150 Foot Embankment with…

in Local (Hopkins) Top News by Madisonville Police Department

Stories Trending Today

December 16, 2014 8128

Coal Miner Fatally Injured in Underground Mining…

in Top News For All Sites by Dick Brown
December 16, 2014 2289

Highway Crews Pre-Treating Roadways for Potential…

in Hopkins News by Keith Todd
December 16, 2014 2251

Madisonville Police Arrest Reports - Dec. 16, 2014

in Hopkins News by Madisonville Police Department
December 15, 2014 2158

Rich Brings Old, New Together in New Album

in Local (Muhlenberg) Top News by Charles W. Riley II, SurfKY News
December 16, 2014 2111

Muhlenberg Community Hospital Installs Biometric…

in Local (Muhlenberg) Top News by Erin Warren
December 16, 2014 1984

KFWC Proposes 2015-2016 Deer Season Dates and…

in General News For All Sites by Department of Fish and Wildlife
December 15, 2014 1976

Dawson Springs Police Reports Released

in Hopkins News by Melissa Heflin
December 16, 2014 1838

Galloway, Director of Provider Services MCH,…

in Local (Muhlenberg) Top News by Karen Robinson
December 16, 2014 1804

MCH Auxiliary Donates $16,000 for the Renovation…

in Local (Muhlenberg) Top News by Erin Warren
December 16, 2014 1532

Hopkins County Joint Planning Commission 2015…

in Hopkins News by Cindy Young

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