Johnson & Johnson — Darzalex FDA Review (BLA761036, ORIG 1, 2015)
Johnson & Johnson · 2015 · FDA Review (openFDA) · company profile →
Report summary
This FDA review summarizes Johnson & Johnson's Biologics License Application for Darzalex (daratumumab) for relapsed/refractory multiple myeloma. It details the proposed indication, dosing, and mechanism of action. Efficacy findings from key clinical trials (MMY2002, GEN501) demonstrated objective response rates and duration of response, supporting an accelerated approval recommendation. The report also covers nonclinical and clinical pharmacology, including pharmacokinetic properties and exposure-response. Safety data highlights infusion reactions, blood compatibility issues, and common adverse events from pooled studies. Regulatory recommendations include postmarketing requirements for further trials and assay validations.
Key findings — cited to the page
| Anemia (16mg/kg, Grade 3-4) | 30 patients | · p.105 |
| Fatigue (16mg/kg, all grade) | 39.10 % | · p.104 |
| Thrombocytopenia (16mg/kg, Grade 3-4) | 28 patients | · p.105 |
| Anemia (16mg/kg, all grade) | 44.87 % | · p.105 |
| Anemia (16mg/kg, Grade 3-4) | 19.23 % | · p.105 |
| Fatigue (16mg/kg, all grade) | 61 patients | · p.104 |
| Grade ≥3 TEAE occurrence rate | 56 % | daratumumab · p.11 |
| Thrombocytopenia (16mg/kg, all grade) | 48.08 % | · p.105 |
| Thrombocytopenia (16mg/kg, Grade 3-4) | 17.95 % | · p.105 |
| Anemia (16mg/kg, all grade) | 70 patients | · p.105 |
| Number of patients with Grade 2 or 3 bronchospasm | 4 | daratumumab · p.11 |
| Fatigue (16mg/kg, Grade 3-4) | 3 patients | · p.104 |
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 →