Bayer submitted a supplemental application to the FDA for NUBEQA, an oral androgen receptor inhibitor combined with androgen deprivation therapy. This application aims to expand the use of NUBEQA in treating metastatic hormone-sensitive prostate cancer (mHSPC) patients, irrespective of chemotherapy use.
The submission is supported by positive results from the ARANOTE trial, presented at ESMO Congress and published in The Journal of Clinical Oncology. NUBEQA, jointly developed by Bayer and Orion Corporation, is an androgen receptor inhibitor that competitively inhibits androgen binding and AR-mediated transcription.
The ARANOTE trial assessed the efficacy and safety of NUBEQA plus ADT in mHSPC patients. The primary endpoint was radiological progression-free survival, while secondary endpoints included overall survival, time to first castration-resistant event, and safety assessments.
NUBEQA is also being evaluated in the ARASTEP trial, comparing NUBEQA plus ADT to ADT alone in HSPC patients with high-risk biochemical recurrence and no evidence of metastatic disease. Additionally, the DASL-HiCaP trial investigates NUBEQA as an adjuvant treatment for localized prostate cancer with a high risk of recurrence.
NUBEQA carries a warning regarding potential ischemic heart disease, with a 3.2% occurrence rate observed in a study of nmCRPC patients. Healthcare professionals should monitor patients for cardiovascular adverse events, including ischemic heart disease.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
