European Commission grants marketing authorisation for expanded use of apalutamide to include treatment of metastatic hormone-sensitive prostate cancer in combination with androgen deprivation therapy (ADT)

Approval was based on data from phase III TITAN study, which demonstrated that combination significantly improved overall survival compared to placebo with ADT, with a 33% relative risk reduction (RRR) in death and 52% RRR in radiographic progression or death.