By Fineline Cube 
German pharmaceutical giant Bayer AG (ETR: BAYN) announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Nubeqa (darolutamide). The approval authorizes its use in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC). This marks the third FDA-approved indication for Nubeqa in the U.S.
Clinical Trial Results
The decision was supported by positive results from the pivotal Phase III ARANOTE trial. The study demonstrated that darolutamide plus ADT reduced the risk of radiographic progression or death by 46% compared to placebo plus ADT in mHSPC patients.
Previous Approvals
Nubeqa, an oral androgen receptor inhibitor (ARi), was previously approved by the FDA for use in combination with docetaxel to treat adult mHSPC patients and for the treatment of adults with non-metastatic castration-resistant prostate cancer (nmCRPC).-Fineline Info & Tech