Astellas submits new prostate cancer drug to EMA
pharmafile | June 28, 2012 | News story | Research and Development, Sales and Marketing | Astellas, EMA, Medivation, NICE, Zytiga, enzalutamide
Astellas has submitted its investigational prostate cancer drug enzalutamide to the European Medicines Agency.
Enzalutamide is a once-daily pill that works as an androgen receptor signalling inhibitor.
Astellas is a seeking a licence for the drug to treat men with metastatic castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.
The submission follows positive results from the pivotal Phase III AFFIRM study, which showed that enzalutamide demonstrated a statistically significant improvement in overall survival with a median improvement over placebo of 4.8 months.
The study also concluded that enzalutamide was generally well tolerated by patients and met all secondary endpoints.
A New Drug Application (NDA) has also been submitted in the US, where Astellas has asked for its drug to be granted a priority review.
If Astellas gains a European licence it will be competing with Janssen’s prostate cancer pill Zytiga (abiraterone), which also just received a final NICE recommendation.
Zytiga, in combination with prednisone, is licensed to treat metastatic castration resistant prostate cancer in men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
It is expected to make between $800 million and $1 billion in peak sales, and is also looking to broaden its licence to treat patients at an earlier stage.
“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, Professor in Experimental Cancer Medicine at 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,” Prof de Bono added.
Astellas has developed the drug with Medivation, based on a global agreement in October 2009, to jointly develop and commercialise enzalutamide.
Subject to receipt of regulatory approval the companies will jointly commercialise enzalutamide in the US, and Astellas will have responsibility for commercialising it in the rest of the world.
Ben Adams
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