XOFIGO  - (ALPHARADIM)  RÁDIO 223
Autor: CANCER DE PROSTATA | Publicado: 2013-05-25T19:14:00-07:00


http://www.algeta.com/news/news-article/?articleId=1702300



Algeta announces that
Xofigo® (radium-223 dichloride) has been approved by the US FDA

Not Intended for US Media

<!--[if !supportLists]-->·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
<!--[endif]-->New treatment for castration-resistant
prostate cancer (CRPC) patients with bone metastases&nbsp;

<!--[if !supportLists]-->·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
<!--[endif]-->Xofigo shown in a pivotal phase III trial to
significantly improve overall survival&nbsp;

<!--[if !supportLists]-->·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
<!--[endif]-->Algeta to host international conference call
scheduled for tomorrow at 08:00 CET - details below&nbsp;

Oslo, Norway, 15 May 2013 - Algeta ASA (OSE:
ALGETA) announces that the US Food and Drug Administration (FDA) has approved
Xofigo®&nbsp;(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 &amp; 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). "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®&nbsp;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.