FX.co ★ Astellas Pharma Gets Positive CHMP Opinion For XTANDI In Early Prostate Cancer Treatment Setting

Astellas Pharma Inc. made an announcement on Friday that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of XTANDI (enzalutamide). It is recommended for use either as a standalone therapy or in combination with androgen deprivation therapy, in treating adult men suffering from high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy.

This favorable CHMP opinion is derived from the results of the Phase 3 EMBARK trial. Following this, the European Commission (EC) will review the opinion. The EC holds the power to grant approval for medicines across all 27 member states of the European Union (EU) as well as in Iceland, Liechtenstein, and Norway.

Furthermore, Astellas plans to hold discussions with other regulatory authorities regarding the EMBARK data to facilitate additional license applications for XTANDI specifically for this indication in 2024 and beyond.