OTTAWA (dpa-AFX) - 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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