Omburtamab I-131 - Y-mAbs Therapeutics

Drug Profile

Omburtamab I-131 - Y-mAbs Therapeutics

Alternative Names: 131 I-8H9; 8H9 MAb; 131I 8H9 (B7-H3); Burtomab I-131; Iodine I 131 monoclonal antibody 8H9; Mab 131-I labelled 8H9

Latest Information Update: 04 Nov 2017

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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; Monoclonal antibodies; Radiopharmaceuticals
  • Mechanism of Action Immunostimulants; Ionising radiation emitters
  • Orphan Drug Status

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

    Yes - Neuroblastoma; Carcinomatous meningitis
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Carcinomatous meningitis; Neuroblastoma
  • Phase I/II Soft tissue sarcoma
  • No development reported Peritoneal cancer; Solid tumours

Most Recent Events

  • 04 Nov 2017 No recent reports of development identified for phase-I development in Peritoneal-cancer(Recurrent, Second-line therapy or greater) in USA (Intraperitoneal)
  • 12 Sep 2017 Y-mAbs Therapeutics plans a phase II trial for Neuroblastoma (In children, In adolescents, In adults) (NCT03275402)
  • 07 Jun 2017 Burtomab -I-131 - Y-mAbs Therapeutics receives Breakthrough Therapy status for Neuroblastoma (Second-line therapy or greater, Metastatic disease, In neonates, In infants, In children) in USA
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