Unituxin(dinutuximab)
Oncology· 49 cited findings· 1 source document
Company: United Therapeutics Corporation →
What the regulatory reviews say
Unituxin (dinutuximab) is indicated for high-risk neuroblastoma. In a study with 226 randomized patients (113 in the experimental arm, 113 in the control arm) with a median age of 3.8 years, Unituxin demonstrated an event-free survival (EFS) improvement of 42% compared to the control arm, with an EFS Hazard Ratio of 0.57 (p-value 0.01). The median event-free survival in the control arm was 1.9 years. The overall survival Hazard Ratio was 0.58. Approximately 36% of patients in the study had MYCN-amplified neuroblastoma.
Key safety findings include Grade 3-5 neuropathic pain (51%), Grade 3-5 pyrexia (40%), Grade 3-5 infusion-related reactions (25%), Grade 3-5 capillary leak syndrome (23%), Grade 3-5 hypotension (16%), Grade 3-5 sepsis (16%), Grade 3-5 device-related infection (16%), Grade 3-5 diarrhea (13%), Grade 3-5 urticaria (13%), and Grade 3-5 hypoxia (12%).
Regulatory information includes IND submission 110494 and a shelf life of 18 months. An expanded access program enrolled 750 patients.
Key figures — cited to the source page
| EFS improvement | 42 | UNITED THERAP — Unituxin FDA Summary Review (NDA/BLA 125516,, p.4 |
| EFS Hazard Ratio | 0.57 | UNITED THERAP — Unituxin FDA Summary Review (NDA/BLA 125516,, p.4 |
| median event-free survival (control arm) | 1.9 | UNITED THERAP — Unituxin FDA Summary Review (NDA/BLA 125516,, p.4 |
| overall survival Hazard Ratio | 0.58 | UNITED THERAP — Unituxin FDA Summary Review (NDA/BLA 125516,, p.4 |
| Grade 3-5 neuropathic pain | 51 | UNITED THERAP — Unituxin FDA Summary Review (NDA/BLA 125516,, p.4 |
| Grade 3-5 pyrexia | 40 | UNITED THERAP — Unituxin FDA Summary Review (NDA/BLA 125516,, p.4 |
| Grade 3-5 infusion-related reactions | 25 | UNITED THERAP — Unituxin FDA Summary Review (NDA/BLA 125516,, p.4 |
| shelf life | 18 | UNITED THERAP — Unituxin FDA Summary Review (NDA/BLA 125516,, p.9 |
Source documents
Explore the full evidence
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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.