Cancer drug prolongs survival

Positive results from Phase III trial on Alpharadin: The drug candidate under development by Bayer and Algeta ASA, Oslo, significantly prolonged the overall survival time of patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases by 44 percent. The ALSYMPCA study thus reached its primary endpoint and all secondary endpoints, including extension of the time until the occurrence of skeleton-related events. The data were presented in September in Stockholm at the multidisciplinary ­European Cancer Congress of the ­European Cancer Organisation, the ­European Society for Medical Oncology and the European Society for Therapeutic Radiology and Oncology during the presidential session.

“The results are really significant,” said Dr. Chris Parker from the Royal Marsden Hospital in London, chief investigator of the ­ALSYMPCA trial. “These data and the results from previous trials suggest that Alpharadin could become a new therapeutic stand­ard for CRPC patients with bone metastases.”

Alpharadin was recently accepted by the U.S. Food and Drug Administration (FDA) for a simplified approval procedure (fast track designation). Fast track status is designed to facilitate the development of drugs to treat severe diseases where there is a high level of unmet medical need and to accelerate assessment by the FDA.

“Prostate cancer is one of the most frequent causes of death in men worldwide. In particular, patients in an advanced stage of the disease whose cancer has already metastasized into the bones urgently require new therapeutic options,” said Dr. Kemal Malik, Head of Global Development at Bayer HealthCare. Bayer plans to submit Alpharadin for regulatory approval in the United States and Europe in mid-2012.