FDA indicates Nubeqa (darolutamide) to treat patients with non-metastatic castration-resistant prostate cancer.
Bayer and Orion Corp. jointly developed the drug, which FDA approved in 2019. The approval came after FDA reviewed results from the Phase 3 ARAMIS study, which tested Nubeqa with androgen deprivation therapy (ADT) in patients with prostate cancer.
The drug has continued to show promise in the Phase 3 ARAMIS trial in supporting metastasis-free survival.
Bayer is currently running a Phase 2 trial of the drug in breast cancer patients.
Filed Under: Oncology