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FDA Grants Fast Track Designation For Alpharadin For Castration Resistant Prostate Cancer In Patients With Bone Metastases

FDA Grants Fast Track Designation For Alpharadin For Castration Resistant Prostate Cancer In Patients With Bone Metastases

Investigational drug Alpharadin (radium-223 chloride) for the treatment of castration-resistant prostate cancer in patients whose cancer has spread to the bone (bone metastasis) has been granted Fast Track designation by the FDA (Food and Drug Administration), Bayer Health Care announced today. Alpharadin is exclusively licenced to Bayer from Algeta ASA.

Castration-resistant prostate cancer (CRPC) used to be known as hormone-refractory prostate cancer (HRPC).

Kemal Malik, MD, Head of Global Development and member of the Bayer HealthCare Executive Committee, said:

“Prostate cancer is a leading cause of death among men all over the world. There is a significant unmet need for patients suffering from the advanced stages of the disease, especially in patients whose cancer has spread to the bone. We are excited that Alpharadin has achieved this important milestone and recognize this fast track designation as an important step in the overall development of Alpharadin, particularly for those patients in need of treatment.”

Alpharadin’s Phase III ALSYMPCA trial met its primary endpoint by considerably improving overall survival of patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases.

An Independent Data Monitoring Committee recommended that the study be stopped and that the patients on placebo be offered Alpharadin therapy. Bayer wrote that the “overall survival result was statistically significant (two-sided p-value = 0.0022, HR = 0.699, the median overall survival was 14.0 months for Alpharadin and 11.2 months for placebo).”

Alpharadin’s safety and tolerability in the Phase III trial was similar with those in Phases I and II.

Fast Track Designation in the USA is given to medications that treat serious diseases and fill an unmet medical need.

Investigational drug, Alpharadin (radium-223 chloride) mimics many of the behaviors of calcium in the bone. It contains an alpha-particle emitting nuclide.

In September 2008, Algeta and Bayer signed an agreement in which Bayer would develop, submit for approvals, and commercialize Alpharadin around the world. Algeta keeps an option for up to 50/50 co-promotion and profit-sharing in the USA.

Alpharadin has not yet been approved by EMA (European Medicines Agency), the FDA or other regulatory authorities – it is an investigational drug.

Prostate cancer is the most common cancer among Americans of Northern European origin. 903,000 males were estimated to have had prostate cancer in 2008 worldwide, and 250,000 died from it.

According to radiological evidence, 90% of males with CRPC have bone metastases. As soon as the cancer settles in bone, it undermines bone strength, often leading to fracture, pain and other complications. Bain metastasis is the main cause of disability and death among individuals with CRPC.

Experts believe Alpharadin has potential sales of over $1 billion.

Written by Christian Nordqvist