Reported Earlier, Astellas' XTANDI (Enzalutamide) Granted European Commission Approval For Use In Additional Recurrent Early Prostate Cancer Treatment Setting
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Astellas' XTANDI (Enzalutamide) has received approval from the European Commission for use in a new treatment setting for high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer in the EU. This makes XTANDI the first novel hormone therapy available for this condition in the EU. The approval is based on the positive results from the Phase 3 EMBARK study, which demonstrated that XTANDI, alone or in combination with leuprolide, significantly reduced the risk of metastasis or death.

April 24, 2024 | 6:23 am
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Astellas Pharma Inc.'s XTANDI has been approved by the European Commission for an additional prostate cancer treatment setting, potentially boosting its market presence in the EU.
The approval of XTANDI for a new treatment setting in the EU represents a significant expansion of its potential market. Given the drug's status as the first novel hormone therapy for this condition in the EU, it is likely to see increased adoption and sales, positively impacting Astellas Pharma Inc.'s financial performance in the short term.
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