UNITED THERAP — Unituxin FDA Summary Review (NDA/BLA 125516, 2015)
United Therapeutics Corporation · 2015 · FDA Summary Review (Drugs@FDA) · company profile →
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The FDA review of Unituxin (dinutuximab) for high-risk pediatric neuroblastoma, based on the ANBL0032 trial, recommended approval due to demonstrated improvements in event-free and overall survival. While the drug presents significant safety concerns, including severe neuropathic pain, pyrexia, and infusion reactions, leading to high discontinuation rates, its benefits in extending survival and delaying relapse were deemed to outweigh these risks by the pediatric oncology community. The approval includes post-marketing requirements for further studies on exposure, safety, allergic reactions, and neutralizing antibody responses.
Key findings — cited to the page
| Grade 3-5 device-related infection | 16 % | · p.4 |
| Grade 3-5 diarrhea | 13 % | · p.4 |
| Grade 3-5 infusion-related reactions | 25 % | · p.4 |
| Grade 3-5 sepsis | 16 % | · p.4 |
| Grade 3-5 urticaria | 13 % | · p.4 |
| Grade 3-5 hypoxia | 12 % | · p.4 |
| Grade 3-5 neuropathic pain | 51 % | · p.4 |
| Grade 3-5 pyrexia | 40 % | · p.4 |
| Grade 3-5 capillary leak syndrome | 23 % | · p.4 |
| Grade 3-5 hypotension | 16 % | · p.4 |
| neuropathic pain (NCI CTCAE Grade 3 or 5) | 51 % | · p.28 |
| pyrexia (NCI CTCAE Grade 3 or 5) | 40 % | · p.28 |
Source: United Therapeutics Corporation ↗ · 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 →