Bayer Aktiengesellschaft — Nubeqa FDA Review (NDA212099, ORIG 1, 2019)
Bayer Aktiengesellschaft · 2019 · FDA Review (openFDA) · company profile →
Report summary
The FDA's multi-disciplinary review of Bayer's NDA 212099 for Darolutamide (Nubeqa) recommends regular approval for treating non-metastatic castration-resistant prostate cancer. The ARAMIS trial, a randomized, double-blind, placebo-controlled study of 1509 patients, demonstrated significant improvement in metastasis-free survival (MFS) with darolutamide (40.4 months vs. 18.4 months for placebo). Nonclinical studies characterized darolutamide as a non-steroidal androgen receptor antagonist with low potential for CNS or cardiac effects. The safety profile was acceptable, with low discontinuation rates due to adverse events and no increased seizure risk. The report details regulatory history, nonclinical pharmacology/toxicology, and clinical pharmacology, including dose adjustments for specific populations and drug interactions. Patient-reported outcomes showed high completion rates for most instruments, with potential benefits for darolutamide in urinary and bowel symptoms.
Key findings — cited to the page
| patients experiencing Grade 3 or 4 Special Topics AE | 33 | ARAMIS · p.136 |
| fatigue (Grade 3-4) | 6 (0.6%) | ARAMIS · p.137 |
| Grade 5 AE (placebo) | 18 (3.2%) | ARAMIS · p.131 |
| patients experiencing Grade 3 or 4 Special Topics AE | 93 | ARAMIS · p.136 |
| hypertension (Grade 3-4) | 3.1% | ARAMIS · p.136 |
| fatigue (all grades) | 151 (16%) | ARAMIS · p.137 |
| arthralgia (Grade 3-4, <65 years) | 0 | ARAMIS · p.146 |
| Grade 5 AE (darolutamide) | 37 (3.9%) | ARAMIS · p.131 |
| Grade 3-4 AE (darolutamide) | 258 (27%) | ARAMIS · p.131 |
| Grade 3-4 AE (placebo) | 125 (23%) | ARAMIS · p.131 |
| fatigue (all grades) | 16% | ARAMIS · p.136 |
| fatigue (all grades) | 63 (11%) | ARAMIS · p.137 |
Source: Bayer Aktiengesellschaft ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →