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# Bayer Files NDA for Prostate Cancer Therapy
- URL: https://www.fdaweb.com/bayer-files-nda-for-prostate-cancer-therapy/
- Published: 2019-04-29T12:00:00.000Z
- Updated: 2026-09-15T01:23:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143979

FDA has accepted for priority review a Bayer NDA for darolutamide for treating non-metastatic castration-resistant prostate cancer (nmCRPC). The submission is based on data from the Phase 3 ARAMIS trial in men with nmCRPC. Darolutamide is an investigational, non-steroidal androgen receptor (AR) antagonist with what the company calls a “distinct chemical structure that binds to the receptor, inhibiting the growth of prostate cancer cells.” Darolutamide is being developed jointly by Bayer and Orion Corp.