Today, Astellas Pharma Inc. (Tokyo: 4503, "Astellas"). announces the
submission of a European marketing authorisation application to the
European Medicines Agency (EMA) for enzalutamide (USAN, MDV3100) for
the treatment of men with metastatic castration-resistant prostate
cancer who have been previously treated with docetaxel-based
chemotherapy.
Enzalutamide is a novel, once-daily investigational oral androgen
receptor signalling inhibitor and the submission follows positive
results from the pivotal phase III AFFIRM study, which confirmed that
enzalutamide demonstrated a statistically significant improvement
(p<0.0001) in overall survival with a median improvement over placebo of
4.8 months [hazard ratio (HR) = 0.631]. The study also
concluded that enzalutamide was generally well tolerated by patients and
met all secondary endpoints. A New Drug Application (NDA)
has been submitted in the United States, where priority review of the
compound has been requested.
"Data from clinical studies, including the phase III AFFIRM study, have
demonstrated that enzalutamide significantly improves overall survival
whilst providing a favourable tolerability profile for patients," said
Professor Johann de Bono, M.D., MSc, Ph.D., FRCP, Honorary Consultant in
Medical Oncology, Professor in Experimental Cancer Medicine, The
Institute of Cancer Research, The Royal Marsden Hospital and
co-principal investigator of the AFFIRM study. "This is vital for
patients at this late stage of their disease and the submission of
enzalutamide represents an important step towards making this promising
treatment available to men with advanced prostate cancer across Europe."
In the phase III AFFIRM trial, common side effects observed more
frequently in enzalutamide as compared with placebo-treated patients
included fatigue, diarrhoea and hot flush. Seizure was reported in < 1%
of enzalutamide-treated patients. Serious adverse events, adverse events
causing patients to stop treatment, and adverse events causing death
were all lower in the enzalutamide group than in the placebo group.
Further positive results from the AFFIRM study relating to the secondary
endpoints of health-related quality of life and time to first
skeletal-related events will also be presented this week at the Global
Congress on Prostate Cancer, Brussels, Belgium. These data
form one of four winning abstracts at the congress and will be presented
by Professor Cora Sternberg of the Department of Medical Oncology, San
Camillo Forlanini Hospital, Rome, Italy.
"Extending life for patients with advanced prostate cancer is of course
a primary goal of treatment, but equally important is that we minimise
the impact of treatment on patient quality of life", said Professor
Sternberg.
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