European Commission Approves Astellas' Xtandi For Recurrent Early Prostate Cancer Treatment

(RTTNews) - Astellas Pharma Inc. (ALPMY) said that the European Commission has approved a label extension for Xtandi or enzalutamide as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer who are unsuitable for salvage-radiotherapy.

The approval was based on results from the positive Phase 3 EMBARK study which showed xtandi alone or in combination with leuprolide reduced the risk of metastasis or death.

The company noted that Xtandi is now the first and only novel hormone therapy available for the treatment of high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer in the European Union.

Xtandi was approved by the U.S. Food and Drug Administration for the treatment of patients with non-metastatic castration-sensitive prostate cancer with biochemical recurrent at high risk for metastasis in November 2023.

Astellas noted that it will reflect the impact from the approval in its financial forecast of the fiscal year ending March 31, 2025 that is scheduled to be disclosed on April 25, 2024.

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