Pick Your Community: | Hopkins | Muhlenberg | Daviess | Christian | Fayette | Henderson | Lakes | McCracken | Warren | 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...

Free Sports Physical Dates Set for Murray, Calloway, Eastwood Students

MURRAY, Ky. (4/19/14) – Murray-Calloway County Hospital will host its annual free sports physicals to local middle and… Read More

Warrant Amnesty Period in Trigg County

CADIZ, Ky. (4/17/14) — The Cadiz Police Department is working with the Trigg County District and Circuit Courts for the… Read More

Most Read This Week (Site-Wide)

April 16, 2014 19355

UPDATE- Sheriff's Office Following Leads…

in Top Stories by Taylor Riley, SurfKY News Reporter
April 17, 2014 4340

KSP Nabs St. Charles Man Wanted by U.S.…

in Top Stories by Trooper Stu Recke
April 15, 2014 3160

Police Searching for Sureway's 'Baby…

in Top Stories by Taylor Riley, SurfKY News Reporter
April 16, 2014 3102

Sheriff's Deputies Nab Central City…

in Top Stories by Sheriff Curtis McGehee
April 15, 2014 2791

Multi-Agency Investigation Leads to Drug…

in Top Stories by Lori Blakeley

Most Read Stories from Hopkins County

April 17, 2014 4340

KSP Nabs St. Charles Man Wanted by U.S.…

in Top Stories by Trooper Stu Recke
April 15, 2014 3160

Police Searching for Sureway's 'Baby…

in Top Stories by Taylor Riley, SurfKY News Reporter
April 15, 2014 2791

Multi-Agency Investigation Leads to Drug…

in Top Stories by Lori Blakeley
April 15, 2014 1085

State Approves $500K for Hopkins Archery…

in Top Stories by Rebecca Hanchett
April 18, 2014 1050

Talking Teen Trashed Telephone Pole,…

in Top Stories by MPD

Most Read Stories from Owensboro

April 15, 2014 1760

Owensboro Police Investigate Auto Accident

in News by Michael Hathaway
April 15, 2014 1391

Owensboro Parks Offers Tennis Lessons

in News by Britni Bunn
April 15, 2014 1056

Happenings and Meetings Owensboro

in News by Dennis Beard, SurfKY News
April 16, 2014 878

New Home Health Care Opens in Owensboro

in News by Dennis Beard, SurfKY News
April 15, 2014 824

OPD’s Annual 5K Run and Police Awareness…

in News by Owensboro Police Department

Most Read Stories from Muhlenberg County

April 16, 2014 3102

Sheriff's Deputies Nab Central City…

in Top Stories by Sheriff Curtis McGehee
April 15, 2014 2066

'Walk Right Back' An Everly Brother's…

in Top Stories by Paul McRee, SurfKY News Reporter
April 15, 2014 1922

Local MCHS Students Train at Job Corps

in Top Stories by Karen Robinson
April 15, 2014 1574

Thumbpickers Unite at Mose Rager Day

in Top Stories by Paul McRee, SurfKY News Reporter
April 16, 2014 1219

South Carrollton Woman Injured in Head-on…

in Top Stories by Trooper Stu Recke

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)

SurfKY Owensboro News Bureau
920 Frederica St. / Suite 210  •  Owensboro, KY 42301  •  270.683-8060 (phone)


Contact a member of our staff: www.surfky.com/contact
Copyright © 2014 SurfKY News Group, Inc.  •  Terms of Use  •  Site Map

social 06social 21social 22social 04social 03