Prostate cancer drug Xtandi gets nod
pharmafile | April 26, 2013 | News story | Sales and Marketing | Xtandi, Zytiga, prostate cancer
Astellas and Medivation have received a positive opinion from Europe’s Committee for Medicinal Products for Human Use (CHMP) for Xtandi, their new prostate cancer treatment.
Xtandi (enzalutamide) has been recommended for the treatment of adult men with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy.
The drug is widely tipped to be a blockbuster, thanks to its impressive data showing it extended life of patients with one of the most advanced forms of prostate cancer.
Analysts forecast the drug could earn $1-2 billion in peak sales, and will provide competition to J&J’s Zytiga, which has been on the market since 2011.
The positive CHMP opinion is based on results from the Phase III AFFIRM study which confirmed that enzalutamide demonstrated a statistically significant improvement (p<0.0001) in overall survival compared to placebo, with a median survival of 18.4 months in the enzalutamide group versus 13.6 months in the placebo group, an advantage 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.
Enzalutamide is a once-daily, oral androgen receptor signalling inhibitor. It inhibits multiple steps in the androgen receptor (AR) signalling pathway, which has been shown to decrease cancer cell growth and can induce cancer cell death (apoptosis).
Astellas anticipates a final decision from the European Commission within the next 60 days. The drug won FDA approval in August.
Professor Johann de Bono, Professor of Experimental Cancer Medicine at The Institute of Cancer Research, London, and head of the Drug Development Unit at The Royal Marsden NHS Foundation Trust, said: “This is an important development in prostate cancer therapeutics that will provide a critically important new treatment option for patients with advanced prostate cancer.
“Enzalutamide has a major impact on quality of life and survival from this common disease, and will hopefully become a key component of prostate cancer treatment initially in late stage disease following chemotherapy.”
Andrew McConaghie
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