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

Algeta: FDA Approves Xofigo (radium-223 dichloride)

Published: Friday, May 17, 2013
Last Updated: Friday, May 17, 2013
Bookmark and Share
Xofigo shown in a pivotal phase III trial to significantly improve overall survival.

Algeta ASA has announced that the US Food and Drug Administration (FDA) has approved Xofigo® (radium-223 dichloride) injection for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

Xofigo is the first alpha particle-emitting radioactive therapeutic agent approved by the FDA, that has demonstrated improvement in overall survival (OS) and delay in time to first symptomatic skeletal event (SSE) compared to placebo, as shown in the pivotal phase III ALSYMPCA trial.

The commercial production of Xofigo is underway, and first doses are expected to be ready for patient treatment within a few weeks. Bayer has worldwide exclusive marketing rights for Xofigo.

Algeta US, LLC and Bayer Healthcare will co-promote the product in the US.

Andrew Kay, Algeta’s President & CEO, said: “We are delighted that the FDA has taken the decision to approve Xofigo so quickly. We are extremely pleased to be able to make this alpha particle-emitting pharmaceutical available to US patients with castration-resistant prostate cancer and symptomatic bone metastases. We will now finalize our launch preparations for Xofigo in the US, with the intention of launching it, with Bayer, as soon as possible. This approval is a major milestone for Algeta and puts us firmly on the path to deliver on our vision to be a world-class oncology company bringing novel targeted medicines to cancer patients through our leadership in alpha particle-emitting pharmaceuticals.”

“The development of bone metastases is a frequent consequence of advanced prostate cancer, and a major cause of disability and death in this disease,” said Dr Chris Parker, Principal Investigator for the pivotal ALSYMPCA trial, from the Royal Marsden Hospital and Institute of Cancer Research (London, UK).

Dr Parker continued, “Xofigo will be an important and welcome addition to the treatment regimes that are used for the treatment of this cancer.”

Bone is the most common site in the body to be affected by metastatic cancer and bone metastases are particularly prevalent in patients with prostate cancer.

Approximately 90% of patients with metastatic prostate cancer show evidence of bone metastases. Bone metastases can lead to an increase in frequency of skeletal events. In addition, bone metastases have been shown to be the main cause of morbidity and death in patients with CRPC.

Efficacy and Safety Data Supporting Xofigo® Approval
The approval of Xofigo (radium-223 dichloride, radium-223) is based on data from the pivotal phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial.

At the interim analysis, radium-223 significantly improved overall survival (OS) [HR=0.695 (95% CI 0.552-0.875), p=0.00185]; median OS was 14.0 months with radium-223 plus best standard of care vs. 11.2 months with placebo plus best standard of care.

Additionally, at the interim analysis there was a delay in the time to first symptomatic skeletal event (SSE) for patients treated with radium-223 vs. placebo.

An updated analysis, conducted after the study was unblinded, showed a further improvement in overall survival (OS) for patients treated with radium-223 vs. placebo, with a median OS of 14.9 months vs. 11.3 months; HR=0.695 (95% CI 0.581-0.832).

The most common adverse reactions (greater than or equal to 10%) in patients receiving radium-223 were nausea, diarrhea, vomiting and peripheral edema.

The most common hematologic laboratory abnormalities (greater than or equal to 10%) of radium-223-treated patients were anemia, lymphocytopenia, leukopenia, thrombocytopenia and neutropenia.

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

Algeta Appoints Dr Andreas Menrad as CSO
Dr Menrad will be responsible for developing and executing the Company’s research strategy.
Monday, August 19, 2013
Algeta Celebrates the Opening of Commercial Production Facility for Xofigo®
Official opening of new facility at the Institute for Energy Technology (IFE) in Kjeller, Norway.
Friday, June 21, 2013
Algeta Announces First Sale of Xofigo® in the United States
First sale triggers EUR 50 million milestone payment from Bayer.
Thursday, May 30, 2013
Algeta’s Partner Bayer Submits Radium-223 for EU Marketing Authorization
Submission to trigger €50 million milestone payment to Algeta.
Monday, April 22, 2013
Algeta Elects New Non-executive Members
Hilde Furberg and Paolo Pucci elected as new members of Algeta’s Board of Directors.
Friday, April 12, 2013
Algeta Initiates New Oncology Research Program to Conjugate Thorium-227 to Epratuzumab
CD22 is a well-validated target for hematological cancers.
Tuesday, January 29, 2013
New Analyses from Phase III ALSYMPCA Trial Presented at ESMO 2012
Radium-223 dichloride (Alpharadin) was significantly superior to placebo in health-related quality of life (QOL) measures.
Monday, October 01, 2012
Updated Phase III Data Confirm Overall Survival Benefit of Alpharadin in Men with CRPC
Submissions seeking marketing approval in US & Europe expected in 2H 2012.
Monday, June 04, 2012
Jeffrey W. Albers Appointed President of Algeta US
Mr. Albers will join Algeta’s executive management team and takes up his position immediately.
Tuesday, January 17, 2012
Algeta Awarded Grant to Develop Targeted Thorium Conjugates
Company has been awarded a NOK 10.5 million grant from the Research Council of Norway.
Tuesday, January 03, 2012
Algeta Appoints Mike Booth as Senior Vice President, Communications and Corporate Affairs
New role created to enhance Algeta's global corporate communications and investor relations activities.
Friday, December 30, 2011
Alpharadin Significantly Improves Overall Survival for CRPC Patients with Bone Metastases
First presentation of full ALSYMPCA phase III data as part of Presidential Session featuring Best and Late-Breaking Abstracts at 2011 EMCC.
Monday, October 10, 2011
Algeta Signs License with Affibody for Tumor-Targeting Molecules
Algeta gains access to two proprietary Affibody® molecules for use in cancer therapy.
Tuesday, August 30, 2011
FDA Grants Fast Track Designation to Alpharadin
Fast Track designation granted to Alpharadin for the treatment of castration-resistant prostate cancer in patients with bone metastases.
Friday, August 26, 2011
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.
Zika Virus Infection Alters Human and Viral RNA
Researchers have discovered that Zika infections results in human and viral genetic modification.
Cell Metabolism Linked to Spread of Cancer
Scientists discover macrophage metabolism can be attuned to prevent the spread of cancer.
Agilent Presents Early Career Professor Award to Dr. Roeland Verhaak
JAX professor recognized for the development and implementation of workflows for the analysis of big-data from transcriptomics to next generation sequencing approaches.
Bacterial Genes Boost Current in Human Cells
Borrowing and tweaking bacterial genes to enhance electrical activity might treat heart, nervous system injury.
Ovarian Cancer Insight
Study showed tumours release cytokines to attract macrophages, which secrete growth factors that in turn promote tumour growth.
Questioning the Safety of Selenium to Combat Cancer
Research indicates the need for change in practice as selenium supplements cannot be recommended for preventing colorectal cancer.
Less Frequent Cervical Cancer Screening
HPV-vaccinated women may only need one screening every 5 to 10 years with screening starting later in life.
Supercomputers Could Improve Cancer Diagnostics
Researchers push the boundaries of cancer research through high-performance computing to map the human immunone.
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