Corporate Banner
Satellite Banner
Medicinal Chemistry
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

FDA Approves New Treatment for a Type of Late Stage Prostate Cancer

Published: Tuesday, September 04, 2012
Last Updated: Tuesday, September 04, 2012
Bookmark and Share
The U.S. Food and Drug Administration today approved Xtandi (enzalutamide) to treat men with late-stage (metastatic) castration-resistant prostate cancer.

Approved for prostate cancer patients previously treated with docetaxel, another anti-cancer treatment, Xtandi was reviewed under the FDA’s priority review program. The program provides for an expedited six-month review for drugs that may offer major advances in treatment or that provide a treatment when no adequate therapy exists. Xtandi received FDA approval three months ahead of the product’s prescription drug user fee goal date of Nov. 22, 2012.

“The need for additional treatment options for advanced prostate cancer continues to be important for patients,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “Xtandi is the latest treatment for this disease to demonstrate its ability to extend a patient’s life.”

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 241,740 men will be diagnosed with prostate cancer and 28,170 will die from the disease in 2012.

The safety and effectiveness of Xtandi was evaluated in a study of 1,199 patients with metastatic castration-resistant prostate cancer who had received prior treatment with docetaxel. The study was designed to measure overall survival (the length of time before death) in men receiving Xtandi compared with men receiving a placebo (sugar pill). The median overall survival for patients receiving Xtandi was 18.4 months, compared with 13.6 months for the patients who received placebo.

The most common side effects observed in study participants taking Xtandi were weakness or fatigue, back pain, diarrhea, joint pain, hot flush, tissue swelling, musculoskeletal pain, headache, upper respiratory infections, dizziness, spinal cord compression and cauda equina syndrome, muscular weakness, difficulty sleeping, lower respiratory infections, blood in urine, tingling sensation, anxiety, and high blood pressure.

Seizures occurred in approximately 1 percent of those receiving Xtandi. Patients in the study who had a seizure stopped Xtandi therapy. The clinical study excluded patients with a history of seizure, an underlying brain injury with loss of consciousness, a temporary decrease in blood to the brain within the past 12 months, a stroke, brain metastases, an abnormal connection of the arteries and veins in the brain, or patients taking medications that may lower the seizure threshold. The safety of Xtandi is unknown in patients with these conditions.


Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,500+ scientific posters on ePosters
  • More than 3,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

US Tox21 to begin screening 10,000 chemicals
A high-speed robotic screening system, aimed at protecting human health by improving how chemicals are tested in the United States, has begun testing the compounds for potential toxicity.
Friday, December 09, 2011
Scientific News
Combining Chemotherapy With Immune-Blocking Drug Could Stop Cancer Growing Back
Giving patients a drug that blocks part of the immune system from going into overdrive might help prevent cancer coming back in some people.
Researchers Pioneer Use of Capsules to Save Materials
Wax capsule delivery systems can simplify a wide range of chemistry transformations.
Photoredox Catalyst Unlocks New Pathways for Nickel Chemistry
Using a light-activated catalyst, researchers have unlocked a new pathway in nickel chemistry to construct carbon-oxygen (C-O) bonds that would be highly valuable to pharmaceutical and agrochemical industries.
Scientists Determine How Antibiotic Gains Cancer-Killing Sulfur Atoms
In a discovery with implications for future drug design scientists have shown an unprecedented mechanism for how a natural antibiotic with antitumor properties incorporates sulfur into its molecular structure, an essential ingredient of its antitumor activity.
Familiar Drugs May Block Ebola Virus Infection
A well-known class of molecules, many of which are already in use therapeutically, may be able to block the Ebola virus’s entry into cells and halt the disease in its tracks, according to researchers at the University of Illinois at Chicago.
New Extra ‘Sticky’ Microgel Could Revolutionise Bladder Cancer Treatment
Researchers have designed a new super-efficient way of delivering an anti-cancer drug which could extend and improve the quality of life for bladder cancer patients - and perhaps save lives.
Common Class of ‘Channel Blocking’ Drugs May Find a Role in Cancer Therapy
Discoveries in fruit flies prompt unusual treatment of patient with metastatic disease.
Common Medications Could Delay Brain Injury Recovery
Drugs used to treat common complaints could delay the recovery of brain injury patients according to research by University of East Anglia (UEA) and University of Aberdeen scientists, published today in Brain Injury.
Scientists Make Strides in Therapy Preventing Addiction Relapse
Single Injection of Drug Candidate Prevents Meth Relapse in Animal Models.
New Clot-Busting Treatments Target Number One Killer
Australian researchers funded by the National Heart Foundation are a step closer to a safer and more effective way to treat heart attack and stroke via nanotechnology.
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!