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131I-omburtamab
- Development stage
- Phase 2
- Lead developer
- Y-mAbs Therapeutics
- Modality
- Antibody-Radionuclide Conjugates → Antibody Conjugates → Antibody-Based Therapeutics, Beta-minus Emitters → Radiopharmaceuticals, Gamma Emitters → Radiopharmaceuticals, Monoclonal Antibodies → Antibody-Based Therapeutics
- Administration
- Intraventricular, Intravenous, Intraperitoneal, Intrathecal
01
Overview
131I-omburtamab is a radiolabeled murine monoclonal antibody designed for targeted radioimmunotherapy. It consists of the antibody omburtamab conjugated to the radioactive isotope iodine‑131. The drug specifically binds to B7-H3 (CD276), an immune checkpoint molecule overexpressed on various tumor cells, including neuroblastoma. Upon binding, it delivers localized beta radiation directly to cancer cells, causing DNA damage and cell death while sparing surrounding healthy tissue. Developed primarily for pediatric patients with central nervous system (CNS) or leptomeningeal metastases from neuroblastoma, it has also been investigated in other embryonal tumors and desmoplastic small round cell tumor (DSRCT). Despite promising clinical data and orphan/rare pediatric disease designations, the FDA declined approval due to insufficient evidence of overall survival benefit in pivotal trials[2][5][9].
- Brand names
- OMBLASTYS
- Other names
- Omburtamab I-131
02
Targets
B7-H3
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