The decision was based on the ARASENS trial, which demonstrated that adding Nubeqa to standard androgen deprivation therapy (ADT) and docetaxel chemotherapy led to a statistically significant improvement in overall survival compared to ADT plus docetaxel and placebo.
The results, published in the New England Journal of Medicine in February, also showed the risk of death was significantly reduced by 32.5% in the Nubeqa group compared to the placebo.