Experimental drug shows great results on prostate cancer

An experimental drug known as MDV3100 made by Medivation Inc. has improved survival rates for men with metastatic castration-resistant prostate cancer. Those on MDV3100 by Medivation outlived those on a placebo by an average of 4.8 months, in a phase 3 trial. The manufacturer Medivation Inc. shares shot up 150% on the news and they announced that an independent committee monitoring the trial recommended stopping the trial after reviewing interim results. It would be unfair and arbitrary to those on the placebo, to continue just for the sake of gathering relatively unneeded data. Howard I. Scher, MD, coprincipal investigator of the AFFIRM study and chief of the genitourinary oncology service at the Memorial-Sloan Kettering Cancer Center in New York City said in a press statement :     "MDV3100 was rationally designed to target androgen-receptor signaling, a key driver of prostate cancer growth ... If approved, MDV3100 will be a welcome option for men with prostate cancers who have progressed on hormones and after initial chemotherapy." The success of MDV3100 is somewhat of a comeback for Medivation Inc and its CEO David Hung as an exciting experimental drug for Alzheimer's failed in late stage testing during 2010. Prostate cancer kills about 250,000 men a year globally and is the second most common cause of cancer death in men in the United States, after lung cancer. Having a better understanding of the molecular abnormalities underlying prostate cancer has led to new approaches such as Medivation's MDV3100. If approved by the FDA MDV3100 will compete with Johnson and Johnson's product Zytiga which is being touted as having great medical and commercial potential. Experts think that MDV3100 looks better than Zytiga though. Professor Johann de Bono, M.D., MSc, Ph.D. FRCP, Honorary Consultant in Medical Oncology, Professor of Cancer Medicine at the Institute of Cancer Research and Royal Marsden Hospital, and the co-principal scientist in the AFFIRM study said :     "MDV3100 has a novel mechanism of action, inhibiting androgen receptor signaling at three distinct points in the signaling pathway ... I am thus particularly pleased with the results of the AFFIRM interim analysis, as there is a real need for new treatments in advanced prostate cancer that target the cancer in different ways." Medivation and its development partner Astellas Pharma Inc. plan to hold a pre-NDA meeting with the Food and Drug Administration (FDA) in early 2012 and will provide an update on regulatory timelines for MDV3100 subsequent to that meeting. Steven Ryder, M.D., president of Astellas Pharma Global Development said :     "We are very excited about these results and will work closely with our alliance partners at Medivation to pursue regulatory submissions in the United States, Europe and Japan ... This is consistent with our corporate commitment to pursue innovative approaches to improving patient care and our strategic intent to be a global catergory leader in oncology."