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Algeta: FDA Approves Xofigo (radium-223 dichloride)

Published: Friday, May 17, 2013
Last Updated: Friday, May 17, 2013
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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.

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