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

e-max.it: your social media marketing partner

LIKE SurfKY on Facebook - Click here to LIKE us now.

© 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.

In Other News...

Madisonville Police Reports Released

MADISONVILLE, Ky. (8/3/15) ― The Madisonville Police Department released the following reports Monday, Aug. 3. Donnie… Read More

Single-Vehicle Fatality Collision on US 641

MARION, Ky. (8/3/15) — The Kentucky State Police is investigating a single-vehicle, fatality collision that occurred on… Read More

Most Read This Week

July 30, 2015 3823

Webster Man Leads Police on Chase through Parts…

by SurfKY News
July 31, 2015 3754

Miss Hopkins County Fair 2015 Chosen

by Tammy Holloway, SurfKY News
July 28, 2015 2847

Hanson, Owensboro, Bowling Green Youths Win at…

by Tammy Holloway, SurfKY News
August 01, 2015 2544

24th Annual Miss Teen Hopkins County Fair Pageant…

by Tammy Holloway, SurfKY News
July 29, 2015 2478

Crime Stoppers Top Most Wanted - July 29, 2015

by SurfKY News

Most Read This Month

July 17, 2015 16685

Muhlenberg Most Wanted - Top 10

by SurfKY News
July 23, 2015 15661

UPDATE: Family Confirms Body of Missing Teen…

by Shawn Freels, SurfKY News

Stories Trending Now

August 02, 2015 1713

Poole Wins Hopkins County Fair Talent Show

by Tammy Holloway, SurfKY News
August 03, 2015 1390

Tiniest Division of Hopkins County Fair Pageants…

by Tammy Holloway, SurfKY News
August 02, 2015 1232

Community Helps ‘Cram the Hummer’ for School…

by Tammy Holloway, SurfKY News
August 03, 2015 1198

Two Injured in Motorcycle Accident

by SurfKY News
August 03, 2015 976

Man Accused of Using Craig's List to Encourage…

by SurfKY News
August 02, 2015 898

Spinal Cord Injury Patient's Foundation Sponsors…

by SurfKY News
August 03, 2015 806

Back To School Bash Brings Crowd to Mall

by Tammy Holloway, SurfKY News
August 02, 2015 599

Legislator's Log - Week of Aug. 2, 2015

by SurfKY News
August 02, 2015 597

'The Free' Gets Greenville Crowd Groovin'

by Mike Groves, SurfKY News
August 03, 2015 569

Vehicle Accident Results in One Fatality

by SurfKY News