TOKYO (dpa-AFX) - Astellas Pharma Inc. announced Friday the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)
adopted a positive opinion recommending approval of XTANDI (enzalutamide) as
monotherapy or in combination with androgen deprivation therapy for the
treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic
hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage
radiotherapy.

The positive CHMP opinion is based on the results from the Phase 3 EMBARK trial.

The positive opinion will now be reviewed by the European Commission (EC), which
has the authority to approve medicines in all 27 European Union (EU) member
states as well as Iceland, Liechtenstein and Norway.

Astellas is also discussing the EMBARK data with other regulatory authorities to
support additional license applications for XTANDI in this indication in 2024
and beyond.



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