Monoclonal antibody 8H9 I-131 - Y-mAbs Therapeutics

Drug Profile

Monoclonal antibody 8H9 I-131 - Y-mAbs Therapeutics

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

Latest Information Update: 13 Dec 2016

Price : $50

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 CD antigen modulators; 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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Carcinomatous meningitis; Neuroblastoma
  • Phase I Peritoneal cancer
  • No development reported Solid tumours

Most Recent Events

  • 13 Dec 2016 Monoclonal antibody 8H9 I-131 - Y-mAbs Therapeutics receives Orphan Drug status for Carcinomatous-meningitis in USA
  • 16 Nov 2016 Monoclonal antibody 8H9 I-131- Y-mAbs Therapeutics receives Orphan Drug status for Neuroblastoma in USA
  • 11 Aug 2016 The US FDA designates rare paediatric disease to 8H9 I-131, for the treatment of relapsed neuroblastoma with CNS leptomeningeal metastasis in USA
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