Drug Profile
Omburtamab I-131 - Y-mAbs Therapeutics
Alternative Names: 131 I-8H9; 8H9-I-131; Burtomab I-131; Iodine I 131 labelled monoclonal antibody 8H9; Iodine I 131 MOAB 8H9; Monoclonal-antibody-8H9-I-131; OMBLASTYSLatest Information Update: 14 Nov 2023
Price :
$50
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At a glance
- Originator Memorial Sloan-Kettering Cancer Center
- Developer Memorial Sloan-Kettering Cancer Center; Y-mAbs Therapeutics
- Class Antineoplastics; Immunotherapies; Iodine radioisotopes; Monoclonal antibody diagnostics; Radiopharmaceutical diagnostics; Radiopharmaceuticals
- Mechanism of Action Antibody-dependent cell cytotoxicity; Immunostimulants; Ionising radiation emitters; Radionuclide imaging enhancers
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Preregistration Neuroblastoma
- Phase II Ependymoma; Medulloblastoma; Peritoneal cancer; Soft tissue sarcoma
- No development reported CNS cancer; Meningeal carcinomatosis; Solid tumours
Most Recent Events
- 31 Oct 2023 Y-mAbs Therapeutics terminates a phase I trial in Peritoneal cancer (In adolescents, In adults, In children, In infants, In the elderly, Metastatic disease, Second-line therapy or greater) in USA (Intraperitoneal) due to corporate business decision (NCT01099644)
- 26 Jun 2023 Y-mAbs Therapeutics, Labcorp Drug Development and Invicro withdraws a phase I trial for Diffuse intrinsic pontine glioma (In adolescents, In adults, In children, In the elderly, Second-line therapy or greater) prior to enrolment (NCT05063357)
- 06 Jan 2023 Y-mAbs Therapeutics anticipates a Type A meeting with the US FDA to discuss potential regulatory pathway for omburtamab in January 2023