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
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 2,400+ 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.


Scientific News
Long Telomeres Associated with Increased Lung Cancer Risk
Genetic predisposition for long telomeres predicts increased lung adenocarcinoma risk.
First Artificial Ribosome Designed
Researchers at the University of Illinois at Chicago and Northwestern University have engineered a tethered ribosome that works nearly as well as the authentic cellular component, or organelle, that produces all the proteins and enzymes within the cell.
Identifying a Key Growth Factor in Cell Proliferation
Researchers discover that aspartate is a limiter of cell proliferation.
A Gene-Sequence Swap Using CRISPR to Cure Haemophilia
For the first time chromosomal defects responsible for hemophilia have been corrected in patient-specific iPSCs using CRISPR-Cas9 nucleases
New Tool Uses 'Drug Spillover' to Match Cancer Patients with Treatments
Researchers have developed a new tool that improves the ability to match drugs to disease: the Kinase Addiction Ranker (KAR) predicts what genetics are truly driving the cancer in any population of cells and chooses the best "kinase inhibitor" to silence these dangerous genetic causes of disease.
New Material Opens Possibilities for Super-Long-Acting Pills
A pH-responsive polymer gel could create swallow able devices, including capsules for ultra-long drug delivery.
New Tool For Investigating RNA Gone Awry
A new technology – called “Sticky-flares” – developed by nanomedicine experts at Northwestern University offers the first real-time method to track and observe the dynamics of RNA distribution as it is transported inside living cells.
Access Denied: Leukemia Thwarted by Cutting Off Link to Environmental Support
A new study reveals a protein’s critical – and previously unknown -- role in the development and progression of acute myeloid leukemia (AML), a fast-growing and extremely difficult-to-treat blood cancer.
New Weapon in the Fight Against Blood Cancer
This strategy, which uses patients’ own immune cells, genetically engineered to target tumors, has shown significant success against multiple myeloma, a cancer of the plasma cells that is largely incurable.
TOPLESS Plants Provide Clues to Human Molecular Interactions
Scientists at Van Andel Research Institute have revealed an important molecular mechanism in plants that has significant similarities to certain signaling mechanisms in humans, which are closely linked to early embryonic development and to diseases such as cancer.
SELECTBIO

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
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!