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US FDA APPROVES XOFIGO (RADIUM-223 DICHLORIDE).

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 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). 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.

About Xofigo (radium-223 dichloride)

Xofigo with the active ingredient radium-223 dichloride (radium-223) is an alpha particle-emitting radioactive therapeutic agent with an anti-tumor effect on bone metastases. Radium-223 mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases. The high linear energy transfer of alpha emitters may cause double-strand DNA breaks in adjacent cells, resulting in an anti-tumor effect on bone metastases. The alpha particle range from radium-223 is less than 100 micrometers which may limit the damage to the surrounding normal tissue.

In September 2009, Algeta signed an agreement with Bayer for the development and commercialization of radium-223. Under the terms of the agreement, Bayer will develop, apply for health authority approvals worldwide and commercialize radium-223 globally. Algeta US, LLC will co-promote radium- 223 with Bayer in the US.

Radium-223 is currently not approved by the European Medicines Agency (EMA) or other authorities outside the US. Bayer submitted a Marketing Authorization Application to the EMA for radium-223 in December 2012 for the treatment of CRPC patients with bone metastases.

About the ALSYMPCA Trial

The ALSYMPCA trial was a phase III, randomized, double- blind, placebo-controlled international study comparing radium-223 dichloride vs. placebo in symptomatic CRPC patients with bone metastases treated with best standard of care compared with placebo plus best standard of care. The trial enrolled 921 patients in more than 100 centers in 19 countries. The study treatment consisted of up to six intravenous injections of radium-223 or placebo each separated by an interval of four weeks.

The primary endpoint of the study was overall survival (OS). A key secondary endpoint was time to first symptomatic skeletal event (SSE), as defined as external beam radiation therapy (EBRT) to relieve skeletal symptoms, new symptomatic pathologic bone fracture, occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention.

About CRPC and Bone Metastases

Prostate cancer is the most common non-cutaneous malignancy in men worldwide. In 2008, an estimated 899,000 men were diagnosed with prostate cancer and 258,000 died from the disease worldwide. Prostate cancer is the sixth leading cause of death from cancer in men.

A majority of men with CRPC have radiological evidence of bone metastases. Once the cancer cells settle in the bone, they interfere with bone strength, often leading to pain, fracture and other complications that can significantly impair a man's health. Bone metastases secondary to prostate cancer typically target the lumbar spine, vertebrae and pelvis. In fact, bone metastases are the main cause of morbidity and death in patients with CRPC.

About the Patient Assistance Program

Bayer and Algeta offer patient assistance through Xofigo Access Services which will assist with obtaining coverage and patient support of Xofigo.

For more information, visit www.xofigo-us.com or call 855/696-3446.
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Publication:Worldwide Biotech
Date:Jun 1, 2013
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