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Omburtamab I-131 - Y-mAbs Therapeutics

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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; OMBLASTYS

Latest Information Update: 14 Nov 2023

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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
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Neuroblastoma; Meningeal carcinomatosis
  • 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
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