DUE TO HEAVY SNOWS IN WESTERN KENTUCKY...WIDESPREAD 6 TO 12 INCH SNOWFALL AMOUNTS HAVE HAULTED AREA TRAVEL. ISOLATED 15 INCH AMOUNTS HAVE BEEN REPORTED. DRIFTS UP TO A FOOT AND A HALF HAVE ALSO BEEN REPORTED. THIS IS A DANGEROUS STORM SITUATION AND TRAVEL SHOULD BE AVOIDED IF AT ALL POSSIBLE. (National Weather Service)
Davis Motor Sales banner ad

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 on social media.

Posted on 2/2/14
springhour
3/13 - 16
3/13 - 16

Most Read This Week

March 02, 2015 9363

Madisonville Teen Faces Numerous Drug Charges

in Local (Hopkins) Top News by Madisonville Police Department/Hopkins County Detention Center
February 25, 2015 8688

Multi-Agency Investigation Nets Large-Scale Meth…

in Top News For All Sites by Trooper Stu Recke
February 25, 2015 6413

New Asian Restaurant Coming to Madisonville

in Local (Hopkins) Top News by Gary Gates, SurfKY News
March 03, 2015 5620

Three Arrested during Traffic Stop

in Local (Hopkins) Top News by Madisonville Police Department/Hopkins County Detention Center
February 25, 2015 4396

Local Man Makes Unique Display from Area’s…

in Local (Hopkins) Top News by Tammy Holloway, SurfKY News
March 02, 2015 3677

HCSO, MPD Join to Bust Alleged Drug Trafficking…

in Local (Hopkins) Top News by Hopkins County Sheriff's Office

Most Read This Month

February 12, 2015

UPDATE: Name of Pennyrile Fatality Officially…

in Top News For All Sites Touching Hopkins by Doreen Dennis, SurfKY News
February 16, 2015

UPDATE: State of Emergency Declared for Kentucky

in Local (Hopkins) Top News by Rita Dukes Smith, SurfKY News Director

Stories Trending Today

March 05, 2015 3527

State of Emergency Declared for Hopkins County

in Local (Hopkins) Top News by Leslie Curneal
March 03, 2015 2585

Superintendent: Spring Break Won't be Touched…

in Hopkins News by Tammy Holloway, SurfKY News
March 05, 2015 1807

KSP Reports Parkway, Interstate Blockages

in Top News For All Sites Touching Hopkins by John Davis, KSP
March 04, 2015 1562

Highway Crews Dealing with Landsides in…

in Local (Muhlenberg) Top News by Keith Todd
March 04, 2015 1386

KSP Warns of Old Scam Resurfacing in the Post 2…

in Top News For All Sites Touching Hopkins by Trooper S. C. Recke
March 04, 2015 1128

Adamson Chosen as Madisonville MSU Campus’…

in Top News For All Sites Touching Hopkins by Tammy Holloway, SurfKY News
March 04, 2015 1095

Madisonville Police Arrest Reports - March 4, 2015

in Hopkins News by Madisonville Police Department
March 04, 2015 1057

Muhlenberg County Educator Inducted into Kentucky…

in Local (Muhlenberg) Top News by WKU News
March 05, 2015 996

Deep Snowfall Stalls Western Kentucky

in Top News For All Sites by SurfKY News
March 04, 2015 887

Mental Health Services Expanded at Western…

in Top News For All Sites Touching Hopkins by Steve Beshear