German pharmaceutical company Bayer AG (BAYZF.PK, BAYRY.PK, BYR.L) announced Thursday the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the oral androgen receptor inhibitor (ARi) NUBEQA (darolutamide) in combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).
The submission is based on positive results from the investigational pivotal Phase III ARANOTE trial that showed NUBEQA plus ADT demonstrated an improvement in radiological progression-free survival (rPFS), significantly reducing in the risk of progression or death in patients with mHSPC compared to placebo plus ADT.
NUBEQA is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.
NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC).