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# Bayer Files Nubeqa sNDA for Prostate Cancer
- URL: https://www.fdaweb.com/bayer-files-nubeqa-snda-for-prostate-cancer/
- Published: 2024-09-26T12:00:00.000Z
- Updated: 2026-09-14T14:42:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157867

Bayer has submitted a supplemental NDA for oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide), seeking approval for its use in combination with androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The drug is currently approved for treating mHSPC in combination with ADT and docetaxel.

The submission is based on data from the Phase 3 ARANOTE trial demonstrating that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT in patients with mHSPC, according to Bayer. “Consistent benefits in radiological progression-free survival were observed across prespecified subgroups, including patients with high- and low-volume mHSPC, it says. Treatment-emergent adverse events were low and similar between treatment groups and consistent with those seen in earlier studies, it adds.

Bayer says the oral ARi has a distinct chemical structure that binds to the androgen receptor with high affinity and exhibits strong antagonistic activity, which inhibits the receptor function and prostate cancer cell growth while minimizing side effects.