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

Radium Ra 223 Dichloride Recommended for Approval in EU

Published: Monday, September 23, 2013
Last Updated: Sunday, September 22, 2013
Bookmark and Share
Approval of radium-223 for the treatment of castration-resistant prostate cancer with bone metastases.

Algeta ASA has announced that Bayer has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending radium Ra 223 dichloride (radium-223) for approval with a proposed indication for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.

The decision of the European Commission (EC) on the approval is expected in the fourth quarter of 2013.

Radium Ra 223 dichloride was approved by the US Food and Drug Administration (FDA) in May under the brand name Xofigo®.

The CHMP recommendation is based on data from the pivotal phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial.

Andrew Kay, Algeta’s President & CEO, said: “Today’s positive opinion from the CHMP marks an important step in the anticipated approval of radium-223 in Europe. This recommendation, soon after Xofigo’s US approval and launch, again highlights the need for a new therapeutic option that has been shown to significantly improve survival in prostate cancer patients whose disease has spread to the bones. We are committed to working with Bayer to ensure patients and physicians in Europe gain access to radium-223 as soon as possible.”

“This recommendation confirms the safety and efficacy of radium-223 as a potential treatment option for patients suffering from castration-resistant prostate cancer with bone metastases, a debilitating and potentially deadly condition,” said Christopher Parker, MD, Principal Investigator of the ALSYMPCA trial and Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust, London, and The Institute of Cancer Research, London.

Parker continued, “There are many men with this disease who could potentially benefit from the availability of radium-223 due to its unique ability to extend life and delay symptomatic skeletal events such as spinal cord compression and the need for external beam radiation therapy for bone pain.”


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 3,000+ scientific posters on ePosters
  • More than 4,400+ 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.


Scientific News
Detection of HPV in First-Void Urine
Similar sensitivity of HPV test on first void urine sample compared to cervical smear.
Potential “Good Fat” Biomarker
New method to measure the activity of energy consuming brown fat cells could ease the testing weight loss drugs.
Shape Of Tumor May Affect Whether Cells Can Metastasize
Illinois researchers found that the shape of a tumor may play a role in how cancer cells become primed to spread.
MicroRNA Pathway Could Lead to New Avenues for Leukemia Treatment
Cancer researchers at the University of Cincinnati have found a particular signaling route in microRNA (miR-22) that could lead to targets for acute myeloid leukemia, the most common type of fast-growing cancer of the blood and bone marrow.
Analysis of Dog Genome will Provide Insight into Human Disease
An important model in studying human disease, the non-coding RNA of the canine genome is an essential starting point for evolutionary and biomedical studies – according to a new study led by The Genome Analysis Centre (TGAC).
New Blood Test for The Earlier Diagnosis of Breast Cancer Spread
Researchers at University of Westminster have confirmed that a new blood test can detect if breast cancer has spread to other parts of the body.
First Gene Therapy Successful Against Human Aging
American woman gets biologically younger after gene therapies.
Targeting an ‘Undruggable’ Cancer Gene
RAS genes are mutated in more than 30 percent of human cancers and represent one of the most sought-after cancer targets for drug developers.
Altered Metabolism of Four Compounds Drives Glioblastoma Growth
Findings suggest new ways to treat the malignancy, slow its progression and reveal its extent more precisely.
Improving Engineered T-Cell Cancer Treatment
Purdue University researchers may have figured out a way to call off a cancer cell assassin that sometimes goes rogue and assign it a larger tumor-specific "hit list."
SELECTBIO

SELECTBIO Market Reports
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
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,400+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!