Phase III study shows enzalutamide offers significant benefit in prostate cancer

USA-based Medivation (Nasdaq: MDVN) and Japanese drug major Astellas (TSE: 4503) has announced the publication in the New England Journal of Medicine of the results from the Phase III AFFIRM trial, an international, randomized, double-blind, placebo-controlled clinical study, showing that enzalutamide (formerly MDV3100) achieved statistically significant benefit in overall survival compared to placebo in metastatic castration-resistant prostate cancer patients.

Astellas acquired rights to the prostate drug candidate Medivation under an agreement worth a potential $765 million to the US firm (The Pharma Letter October 27, 2009). Enzalutamide is currently under review by the US Food and Drug Administration with a Prescription Drug User Fee Act (PDUFA) action date set for November 22, 2012 (The Pharma Letter August 7). The drug has also been filed for European Union approval (TPL June 28).

"The AFFIRM data represent an important body of clinical evidence on enzalutamide, a novel oral androgen receptor signaling inhibitor, as a potential new treatment that can prolong the lives of men with advanced prostate cancer. The achievement underlines the importance of integrating clinical observations and basic research to significantly improve patient outcomes and bring therapies to patients faster. It is extremely gratifying to share these results with the medical community," said Howard Scher, chief, Genitourinary Oncology Service at Memorial-Sloan Kettering Cancer Center, the co-principal investigator and lead author of the AFFIRM study paper.