EMA recommends apalutamide for nmCRPCJanuary 14, 2019
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for apalutamide for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).
Apalutamide is an investigational, next-generation oral androgen receptor inhibitor that blocks the androgen signalling pathway in prostate cancer cells.
Janssen Pharma submitted the data from the pivotal SPARTAN phase 3 clinical study which assessed the safety and efficacy of apalutamide versus placebo in patients with nmCRPC who have a rapidly rising prostate-specific antigen (PSA) level despite receiving continuous androgen deprivation therapy (ADT).
The SPARTAN clinical study showed that apalutamide, when added to ADT, significantly reduced the risk of developing distant metastasis or death (metastasis-free survival [MFS]) by 72% compared to placebo in combination with ADT.