Posted by Michael Wonder on 10 Feb 2018
Janssen submits marketing authorisation application for apalutamide to treat patients with high-risk non-metastatic castration-resistant prostate cancer
9 February 2018 - Phase 3 SPARTAN data showed apalutamide improved median metastasis-free survival by over two years compared to placebo.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that it has submitted a marketing authorisation application to the EMA for apalutamide, an investigational, next generation oral androgen receptor inhibitor for the treatment of patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC).
The submission is based on data from the pivotal SPARTAN Phase 3 clinical trial which assessed the safety and efficacy of apalutamide versus placebo in men with nmCRPC who have a rapidly rising prostate specific antigen level, despite receiving continuous androgen deprivation therapy (ADT). The SPARTAN clinical trial showed a significantly decreased risk of distant metastasis or death (definition of the primary endpoint, metastasis free survival) by 72 percent, compared to placebo in combination with ADT (HR = 0.28; 95% CI, 0.23-0.35; P < 0.0001) and improved median metastasis-free survival by over two years (difference of 24.3 months) in patients with nmCRPC whose PSA is rapidly rising.
