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I-131-Apamistamab - Actinium Pharmaceuticals

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Drug Profile

I-131-Apamistamab - Actinium Pharmaceuticals

Alternative Names: 131-I-labeled anti-CD45 antibody; 131-I-labeled BC8 antibody; 131I-BC8 (anti-CD45) antibody - Actinium Pharmaceuticals; Anti-CD45 monoclonal antibody-BC8-I-131; Anti-CD45 monoclonal antibody-I-131; BC 8; BC8-I-131 construct; I-131-BC8; I131-Apamistamab; Iodine I 131 Apamistamab; Iodine-131-apamistamab; Iomab-ACT; Iomab-B

Latest Information Update: 07 Aug 2024

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At a glance

  • Originator Fred Hutchinson Cancer Research Center
  • Developer Actinium Pharmaceuticals; Fred Hutchinson Cancer Research Center; Memorial Sloan-Kettering Cancer Center
  • Class Antineoplastics; Immunoconjugates; Iodine radioisotopes; Monoclonal antibodies; Radiopharmaceuticals
  • Mechanism of Action Ionising radiation emitters
  • Orphan Drug Status

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

    Yes - Acute myeloid leukaemia
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Acute myeloid leukaemia
  • Phase II Myelodysplastic syndromes; Precursor cell lymphoblastic leukaemia-lymphoma
  • No development reported Diffuse large B cell lymphoma; Hodgkin's disease; Non-Hodgkin's lymphoma; Precursor B-cell lymphoblastic leukaemia-lymphoma

Most Recent Events

  • 05 Aug 2024 Actinium plans to request a meeting with the US FDA to further discuss specifics of additional trial
  • 05 Aug 2024 the US FDA determines that the Phase III SIERRA trial is not adequate to support a BLA filing for Iomab-B and asks for additional investigations
  • 01 Aug 2024 Actinum Pharmaceuticals has patent protection for composition of matter patents covering Iomab-ACT in the US, until 2040

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