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Astellas' new hormone-sensitive prostate cancer drug Xtandi receives EU approval for its new indication

 Last Update: 2021-05-22
 Source: Internet
 Author: User

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Recently, Astellas announced that the European Commission has approved a new indication for Xtandi: for the treatment of adult patients with metastatic hormone-sensitive prostate cancer.

This approval is based on data from the pivotal Phase 3 ARCHS study (NCT02677896).

The results showed that the study reached the primary endpoint of imaging progression-free survival (rPFS): Compared with the placebo+ADT regimen group, the Xtandi+ADT regimen group significantly reduced the risk of radiological progression or death by 61% (HR=0.

Original source: Astellas' XTANDI (enzalutamide) approved by European Commission for Men with Metastatic Hormone-Sensitive Prostate Cancer

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