Posted by Michael Wonder on 25 Jul 2019
Astellas announces acceptance by the EMA of a variation application for regulatory review for use of Xtandi (enzalutamide) in metastatic hormone-sensitive prostate cancer
24 July 2019 - Astellas Pharma announced the acceptance by the EMA of a Type II variation application for regulatory review for the use of Xtandi (enzalutamide) in metastatic hormone-sensitive prostate cancer patients.
The Type II variation application is based on data from both the pivotal Phase 3 ARCHES trial, and the Phase 3 ENZAMET trial, investigating enzalutamide in men with metastatic hormone-sensitive prostate cancer.
