The US Food and Drug Administration (FDA) has approved Belgium-based Janssen Pharmaceutical's androgen receptor inhibitor, Erleada (apalutamide), intended for the treatment of non-metastatic castration-resistant prostate cancer (NM-CRPC), it was reported yesterday.
The FDA approval received by the subsidiary of Johnson & Johnson comes after last week's results of the phase three SPARTAN trial in patients with NM-CRPC in which the drug was indicated to have decreased the risk of distant metastasis or death by 72%. The product was also indicated to have increased the median metastasis-free survival by more than two years in comparison with placebo.
The trial assessed the efficacy and safety of the product in comparison to placebo in over 1,200 men with NM-CRPC who had a rapidly increasing PSA while being subjected to continuous androgen deprivation therapy. The product is now the first approved treatment in the United States for NM-CRPC.
Scancell initiates SCOPE trial's iSCIB1+ cohort
Bio-Thera Solutions' BAT8006 phase II Study receives US FDA IND approval
Poseida Therapeutics names new chief medical officer
Biocytogen and ABL Bio collaborate on development of new bispecific antibody-drug conjugates
BioVaxys Technology announces non-brokered private placement
Senhwa Biosciences doses first subject in phase II study of Silmitasertib
Antennova completes first dosing cohort in Phase one study of ATN-031
M8 Pharmaceuticals collaborates with SERB Pharmaceuticals
BerGenBio ASA starts Phase 2a portion of BGBC016 clinical study of bemcentinib
Phanes Therapeutics receives FDA Fast Track designation for PT886