JANSSEN BIOTECH — Darzalex FDA Summary Review (NDA/BLA 761036, 2015)
Johnson & Johnson · 2015 · FDA Summary Review (Drugs@FDA) · company profile →
Report summary
The FDA summary review of Janssen's DARZALEX (daratumumab) Biologics Licensing Application details its approval for multiple myeloma. Granted Breakthrough Therapy Designation and priority review, this anti-CD38 monoclonal antibody demonstrated efficacy in two single-arm trials (MMY2002 and GEN501), achieving overall response rates of 29% and 36%, with median response durations of 7.4 and 6.9 months, respectively. Key safety concerns identified include infusion-related reactions and potential interference with blood bank and serum protein electrophoresis testing.
Key findings — cited to the page
| Regulatory action | Accelerated Approval | · p.11 |
| Breakthrough Therapy Designation granted date | May 1, 2013 | · p.3 |
| Review type | priority review | · p.3 |
| Median Duration of Response (DOR) in GEN501 (16 mg/kg dose) | 6.9 months | GEN501 · p.10 |
| Orphan designation | granted | · p.11 |
| Application type | Biologics Licensing Application | DARZALEX · p.3 |
| Daratumumab dosing regimen | 16 mg/kg body weight | · p.8 |
| Number of patients in PK analysis | 223 | · p.8 |
| Trial phase for GEN501 | phase 1/2 | GEN501 · p.9 |
| Trial phase for MMY2002 | phase 2 | MMY2002 · p.9 |
| Number of individuals in MMY2002 16 mg/kg cohort | 106 | MMY2002 · p.9 |
| Overall Response Rate (ORR) in MMY2002 | 29% | MMY2002 · p.10 |
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 →