Bayer Looking to Expand Nubeqa Indication

Based on positive results from the Phase 3 ARANOTE trial of its Nubeqa (darolutamide) in men with metastatic hormone-sensitive prostate cancer, Bayer says it will discuss with FDA a regulatory submission to expand the drug’s indication.

A company statement says the trial of Nubeqa with androgen deprivation therapy (ADT) met its primary endpoint, significantly increasing radiological progression-free survival compared to placebo plus ADT. No new safety signals were observed in the trial, the company says.

Nubeqa is described as an androgen receptor inhibitor with a distinct chemical structure that competitively inhibits androgen binding, androgen receptor nuclear translocation, and androgen receptor-mediated transcription. It is currently indicated in the U.S. in combination with docetaxel and ADT to treat adults with metastatic hormone-sensitive prostate cancer and to treat adults with non-metastatic castration-resistant prostate cancer with ADT.