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news.The European Commission (EC) has granted a variation to amend the marketing authorization for Astellas Pharma's enzalutamide (XTANDI) to treat men with metastatic castration-resistant prostate cancer (mCRPC).
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The drug is now approved to treat these mCRPC patients who are asymptomatic or mildly symptomatic after failure of androgen-deprivation therapy in whom chemotherapy is not yet clinically indicated.
The European approval is based on results from the pivotal Phase III PREVAIL trial which showed that enzalutamide improves outcomes for men with advanced prostate cancer who have not received chemotherapy.
More than 1,700 patients at sites in the US, Canada, Europe, Australia, Russia, Israel and Asia including Japan were enrolled in the trial, which was designed to evaluate enzalutamide at a dose of 160mg taken orally once daily versus placebo.
In the randomized, double-blind, placebo-controlled, multi-national trial, the company enrolled patients with chemotherapy-naïve metastatic prostate cancer whose disease progressed on a luteinising hormone-releasing hormone analogue or after bilateral orchiectomy.
The trial’s co-primary endpoints were overall survival and radiographic progression-free survival.
The company intends to launch enzalutamide in the pre-chemotherapy setting in the first European countries, including the UK, from December 2014.
The approval of this new indication for enzaltamide triggers $45m in milestone payments to Medivation as part of its collaboration agreement with Astellas.