Posted by Michael Wonder on 22 Mar 2024
Astellas receives positive CHMP opinion for Xtandi in additional recurrent early prostate cancer treatment setting
22 March 2024 - If approved, XTANDI would become the first and only NHT treatment available for metastatic and high risk biochemical recurrent non-metastatic hormone sensitive prostate cancer patient populations in the European Union.
Astellas Pharma today announced 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.
