Bayer’s NUBEQA Shows Promise in Prostate Cancer Treatment, Expanding Indications

1. NUBEQA (darolutamide): An androgen receptor inhibitor (ARi) developed jointly by Bayer and Orion Corporation, indicated for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel.
2. ARASENS Trial: A randomized, Phase III, multi-center, double-blind, placebo-controlled trial demonstrating the efficacy of NUBEQA plus androgen deprivation therapy (ADT) and docetaxel in patients with mHSPC.
3. ARAMIS Trial: A randomized, double-blind, placebo-controlled, multi-center Phase III study evaluating the safety and efficacy of oral NUBEQA in patients with nmCRPC, leading to FDA approval on July 30, 2019.
4. Ongoing Trials: NUBEQA is being investigated in additional studies, including the Phase III ARANOTE trial, the ARASTEP trial, and the DASL-HiCaP trial, across various stages of prostate cancer.
5. Recent Successes: Positive topline results from a Phase III trial in men with metastatic hormone-sensitive prostate cancer, supporting the expansion of NUBEQA's indications.