Darzalex
Oncology· 301 cited findings· 3 source documents
Company: Johnson & Johnson →
What the regulatory reviews say
Darzalex (daratumumab) is a medication indicated for the treatment of multiple myeloma. Regulatory review documents detail its efficacy and safety profile, leading to its approval. The drug demonstrated an Objective Response Rate (ORR) of 29% in one study (MMY2002) and 36% in another (GEN501 at 16 mg/kg dose). The median duration of response was 7.4 months in MMY2002 and 6.9 months in GEN501 (16 mg/kg dose).
Safety findings include a Grade ≥3 treatment-emergent adverse event (TEAE) occurrence rate of 56%. The median time of onset for infusion reactions was 90 minutes, and 40% of infusions were interrupted due to adverse reactions. Common adverse events included thrombocytopenia (48.08% all grade, 17.95% Grade 3-4 at 16mg/kg) and anemia (44.87% all grade, 30 patients Grade 3-4 at 16mg/kg).
Darzalex received an Accelerated Approval from the FDA on October 28, 2015, following a Priority review of its Original Biologics License Application (BLA 761036) submitted on July 9, 2015. Postmarketing requirements include submitting final reports for trials MMY3003 and MMY3004, evaluating daratumumab in combination with other therapies for previously treated multiple myeloma.
Key figures — cited to the source page
| Overall Response Rate (ORR) in MMY2002 | 29% | JANSSEN BIOTECH — Darzalex FDA Summary Review (NDA/BLA 76103, p.10 |
| Median Duration of Response (DOR) in MMY2002 | 7.4 | JANSSEN BIOTECH — Darzalex FDA Summary Review (NDA/BLA 76103, p.10 |
| Overall Response Rate (ORR) in GEN501 (16 mg/kg dose) | 36% | JANSSEN BIOTECH — Darzalex FDA Summary Review (NDA/BLA 76103, p.10 |
| Grade ≥3 TEAE occurrence rate | 56 | Johnson & Johnson — Darzalex FDA Review (BLA761036, ORIG 1,, p.11 |
| Thrombocytopenia (16mg/kg, all grade) | 48.08 | Johnson & Johnson — Darzalex FDA Review (BLA761036, ORIG 1,, p.105 |
| Anemia (16mg/kg, all grade) | 44.87 | Johnson & Johnson — Darzalex FDA Review (BLA761036, ORIG 1,, p.105 |
| Regulatory Recommendation | Accelerated Approval | Johnson & Johnson — Darzalex FDA Review (BLA761036, ORIG 1,, p.79 |
| Review Date | 28 October 2015 | Johnson & Johnson — Darzalex FDA Review (BLA761036, ORIG 1,, p.2 |
Source documents
Explore the full evidence
All 301 cited findings for Darzalex — searchable, comparable and answerable in plain language — are in the Oncology research library →
Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.