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# Bayer Looking to Expand Nubeqa Indication
- URL: https://www.fdaweb.com/bayer-looking-to-expand-nubeqa-indication/
- Published: 2024-07-17T12:00:00.000Z
- Updated: 2026-09-14T14:35:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157374

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](https://www.businesswire.com/news/home/20240716341886/en/Bayer-announces-positive-topline-results-for-NUBEQA%C2%AE-darolutamide-from-Phase-III-trial-in-men-with-metastatic-hormone-sensitive-prostate-cancer-mHSPC?ref=fdaweb.com) 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.