Corporate Banner
Satellite Banner
Scientific Communities
Become a Member | Sign in
Home>News>This Article

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

Join For Free

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 3,500+ scientific posters on ePosters
  • More Than 5,200+ 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 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

FDA Isolates Hepatitis A Outbreak Origin
The FDA and CDC are aiding the Hawaii Department of Health investigation into hepatitis A virus (HAV) infections linked to imported scallops.
Monday, August 22, 2016
US Bans Three Food Packaging Chemicals
New ban includes three specific perfluoroalkyl ethyl containing food-contact substances (FCSs.
Friday, January 08, 2016
FDA Awards Breakthrough Therapy Designation to Boehringer’s Lung Cancer Candidate
Boehringer Ingelheim Pharmaceuticals has scored FDA breakthrough therapy designation for its candidate to treat patients with T790M mutation-positive non-small cell lung cancer.
Wednesday, January 06, 2016
FDA OK’s AquAdvantage Salmon
After an exhaustive and rigorous scientific review, FDA has arrived at the decision that AquAdvantage salmon is as safe to eat as any non-genetically engineered (GE) Atlantic salmon, and also as nutritious.
Monday, November 23, 2015
Advancing Precision Medicine by Enabling a Collaborative Informatics Community
The FDA is developing an informatics platform that will facilitate the sharing of expertise of knowledge in the field of precision medicine.
Wednesday, August 12, 2015
FDA Declares Trans Fatty Acids Unsafe for Consumption
TFAs are widely recognized as the most harmful fat with regard to causing cardiovascular disease (CVD).
Wednesday, July 15, 2015
FDA Seeks $4.9 billion to Implement the FDA Food Safety Modernization Act
FY 2016 request reflects a nine percent increase from FY 2015 budget, aims to improve the quality and safety of the medical products Americans use.
Monday, February 23, 2015
FDA Issues Additional Guidance For Outsourcing Facilities That Compound Sterile Human Drugs
Agency outlines details on registration, fees, and drug product reporting for outsourcing facilities.
Tuesday, November 25, 2014
FDA Rules Will See Calorie Counts on Menus
The menu labeling final rule applies to restaurants and similar retail food establishments if they are part of a chain of 20 or more locations.
Tuesday, November 25, 2014
FDA Food Safety Challenge
Challenge aims to spur new technologies for fighting foodborne illness.
Friday, September 26, 2014
FDA Allows Marketing of T2Candida
FDA allows marketing of the first test to identify five yeast pathogens directly from a blood sample.
Tuesday, September 23, 2014
FDA Issues Guidance on Use of Nanotechnology in Food Production
The three final guidances and one draft guidance provide greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.
Tuesday, July 01, 2014
FDA Proposes New Expedited Access Program for Medical Devices
New program would provide earlier access to high-risk medical devices that address unmet needs in the treatment or diagnosis of patients with serious conditions.
Tuesday, April 22, 2014
FDA, EMA Strengthen Pharmacovigilance Collaboration
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have set-up a new 'cluster' on pharmacovigilance topics.
Thursday, February 20, 2014
FDA Approves First Generic Versions of Antidepressant Drug Cymbalta
The U.S.FDA approved the first generic versions of Cymbalta), a prescription medicine used to treat depression and other conditions.
Monday, December 16, 2013
Scientific News
Integrated Omics Analysis
Studying multi-omics promises to give a more holistic picture of the organism and its place in its ecosystem, however despite the complexities involved those within the field are optimistic.
Unravelling the Role of Key Genes and DNA Methylation in Blood Cell Malignancies
Researchers from the University of Nebraska Medical Center have demonstrated the role of Dnmt3a in safeguarding normal haematopoiesis.
Salford Lung Study - The First Real World Clinical Trial
In this podcast, we learn about the Salford Lung Study and its potential to revolutionize the way we assess new drugs and treatments around the world.
Point of Care Diagnostics - A Cautious Revolution
Advances in molecular biology, coupled with the miniaturization and improved sensitivity of assays and devices in general, have enabled a new wave of point-of-care (POC) or “bedside” diagnostics.
RNA-Binding Proteins Role in ALS Revealed
Researchers describe how damage to RNA-binding protein contributes to ALS, isolating a possible therapeutic target.
Zika Virus Infection Alters Human and Viral RNA
Researchers have discovered that Zika infections results in human and viral genetic modification.
MRIs for Fetal Health
Algorithm could help analyze fetal scans to determine whether interventions are warranted.
Mapping Serotonin in the Living Brain
Imaging technique that creates a 3D video of serotonin transport could aid antidepressant development.
Structure of Primary Cannabinoid Receptor is Revealed
The findings provide key insights into how natural and synthetic cannabinoids including tetrahydrocannabinol —a primary chemical in marijuana—bind at the CB1 receptor to produce their effects.
Overlooked Molecules Could Revolutionise our Understanding of the Immune System
Researchers have discovered that around one third of all the epitopes displayed for scanning by the immune system are a type known as ‘spliced’ epitopes.
Scroll Up
Scroll Down
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
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,200+ scientific videos