Japanese pharmaceutical company Astellas Pharma Inc (TSE:4503) announced on Friday that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for XTANDI (enzalutamide), signifying its recommendation for approval as monotherapy or in combination with androgen deprivation therapy.

This endorsement applies to the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy.

Following CHMP's decision, the European Commission will assess the recommendation. A decision on EU marketing authorisation is anticipated by June 2024.

Ahsan Arozullah, MD, MPH, senior vice president and head of Oncology Development at Astellas, highlighted the significance of this advancement, citing the urgent need for effective treatments, especially considering the high probability of disease progression among this patient group.

The favourable CHMP opinion was based on data derived from the Phase 3 EMBARK trial, presented at the 2023 American Urological Association Annual Meeting and subsequently published in the New England Journal of Medicine.

Astellas is also in dialogue with other regulatory bodies to extend XTANDI's indications beyond its current approvals.