Johnson & Johnson — Erleada FDA Review (NDA210951, ORIG 1, 2018)
Johnson & Johnson · 2018 · FDA Review (openFDA) · company profile →
Report summary
The FDA recommended regular approval for Erleada (apalutamide) for non-metastatic, castration-resistant prostate cancer (NM-CRPC) based on the SPARTAN trial. This Phase 3 study demonstrated significant improvement in metastasis-free survival (MFS), a new primary endpoint for this indication. The drug, a novel androgen receptor inhibitor, showed acceptable safety, with common toxicities including rash, weight loss, falls, and fractures. Nonclinical and clinical pharmacology assessments supported the proposed dosing, detailing pharmacokinetics, metabolism, and drug interactions. While interim overall survival did not reach significance, other secondary endpoints favored apalutamide. No dose adjustments are needed for mild to moderate hepatic or renal impairment, but severe hepatic impairment is not recommended.
Key findings — cited to the page
| Grade 5 AE | 1.2 % | SPARTAN · p.128 |
| Grade 3-4 AE | 362 n | SPARTAN · p.128 |
| hypertension (Grade 3-4) | 14 % | · p.141 |
| Lymphopenia (Grades 3-4) | 1.6 % | SPARTAN · p.135 |
| Grade 5 AE | 1 n | SPARTAN · p.128 |
| Grade 5 AE | 0.3 % | SPARTAN · p.128 |
| hyperglycemia (Grade 3-4, placebo) | 4 % | · p.141 |
| hypertension (all-grade) | 25 % | · p.141 |
| hypertension (all-grade, placebo) | 20 % | · p.141 |
| hypertension (Grade 3-4, placebo) | 12 % | · p.141 |
| Grade 5 AE | 10 n | SPARTAN · p.128 |
| Grade 3-4 AE | 45 % | SPARTAN · p.128 |
Source: Johnson & Johnson ↗ · 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 →