Posted by Michael Wonder on 29 Jan 2019
Janssen announces European Commission approval of Erleada (apalutamide) for non-metastatic castration-resistant prostate cancer patients who are at high risk of developing metastatic disease
16 January 2019 - Phase 3 SPARTAN data served as basis for approval, which showed apalutamide decreased the risk of distant metastasis or death by 72% and improved median metastasis-free survival by more than two years.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Commission has granted marketing authorisation for Erleada (apalutamide), a next generation oral androgen receptor inhibitor for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.
The European Commission approval is based on data from the pivotal Phase 3 SPARTAN study, which was published in The New England Journal of Medicine.
