Astellas Pharma and Medivation have submitted a variation to amend the European marketing authorisation application (MAA) for Xtandi (enzalutamide) capsules to treat adult men with metastatic castration-resistant prostate cancer (mCRPC).
Xtandi is indicated for mCRPC patients who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated.
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Currently, the drug is approved in Europe for treatment of adult males with mCRPC whose disease has progressed on or after docetaxel chemotherapy.
The MAA is based on the results from the Phase III PREVAIL trial evaluating Xtandi as compared to placebo in over 1,700 chemotherapy-naive mCRPC patients.
The randomised, double-blind, placebo-controlled, multi-national Phase III PREVAIL trial enrolled more than 1,700 patients with chemotherapy-naïve metastatic prostate cancer whose disease progressed on a luteinising hormone-releasing hormone analogue or after bilateral orchiectomy.
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The trial enrolled patients at sites in the US, Canada, Europe, Australia, Russia, Israel and Asian countries including Japan. It was designed to evaluate enzalutamide at a dose of 160mg taken orally once daily versus placebo.
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By GlobalDataThe trial’s co-primary endpoints were overall survival and radiographic progression-free survival.
The company said that Xtandi is an androgen receptor inhibitor that acts on different steps in the androgen receptor signalling pathway.
The capsules have been shown to competitively inhibit androgen binding to androgen receptors, and inhibit androgen receptor nuclear translocation and interaction with DNA.
The European Commission has earlier granted marketing authorization for Xtandi on 21 June 2013.
Astellas and Medivation filed a supplemental new drug application for Xtandi in March 2014, for treatment of men with mCRPC who have not received chemotherapy to the US Food and Drug Administration (FDA).
Xtandi was approved by the US FDA in August 2012 and is indicated for treatment of patients with mCRPC who have previously received docetaxel.
Image: Micrograph of prostate adenocarcinoma, acinar type, the most common type of prostate cancer. Photo: courtesy of Nephron.
