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.

In Other News...

KSP To Partner With DEA For Ninth National 'Take Back' Initiative

MADISONVILLE, Ky. (9/18/14) — The Kentucky State Police will partner with the Drug Enforcement Administration Saturday,… Read More

Crime Stoppers Fugitive of the Week – Sept. 17, 2014

HOPKINSVILLE, Ky. (9/17/14) — The above photos are local fugitives that are currently being sought by local… Read More

Most Read This Week (Site-Wide)

September 15, 2014 5145

Man Accused of Stealing Rural King…

in Top Stories by MCSO PIO Alex Piper
September 15, 2014 4894

Man Accused of Stalking Woman During Her…

in Top Stories by GPD PIO Wes Miller
September 16, 2014 3783

Postal Worker Arrested for Terroristic…

in Top Stories by GPD PIO Wes Miller
September 17, 2014 2736

Wanted Man Leads Troopers on Chase…

in Top Stories by Trooper Stu Recke
September 17, 2014 2558

Two Arrested for Meth After Traffic Stop

in Top Stories by Alex Piper

Most Read Stories from Hopkins County

September 17, 2014 2736

Wanted Man Leads Troopers on Chase…

in Top Stories by Trooper Stu Recke
September 15, 2014 2353

Man Arrested for DUI, Carrying Concealed…

in Top Stories by Madisonville Police Department
September 15, 2014 2230

Man Arrested for Being Under Influence of…

in Top Stories by Madisonville Police Department
September 17, 2014 1813

Three Injured in Two-Vehicle Accident

in Top Stories by Kyle Pharris
September 18, 2014 1277

Manitou Man Charged with DUI

in Top Stories by Madisonville Police Department

Most Read Stories from Owensboro

September 15, 2014 1446

Owensboro Convention Center Announces…

in News by Madison Strobel
September 15, 2014 1127

Marian Retreat Oct. 18-19

in News by Jennifer Kaminski
September 14, 2014 1064

Come and Explore at Sister Trek 2014

in News by Jennifer Kaminski
September 15, 2014 1005

Parking Committee Meeting Location Change

in News by Beth Cecil
September 15, 2014 475

Owensboro Man Charged With Burglary,…

in Top Stories by Dennis Beard, SurfKY News

Most Read Stories from Muhlenberg County

September 15, 2014 5145

Man Accused of Stealing Rural King…

in Top Stories by MCSO PIO Alex Piper
September 15, 2014 4894

Man Accused of Stalking Woman During Her…

in Top Stories by GPD PIO Wes Miller
September 16, 2014 3783

Postal Worker Arrested for Terroristic…

in Top Stories by GPD PIO Wes Miller
September 17, 2014 2558

Two Arrested for Meth After Traffic Stop

in Top Stories by Alex Piper
September 14, 2014 2212

Three Injured in Single-Car Collision

in Top Stories by Robert LIttlepage

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