Isatuximab - Immunogen/Sanofi

Drug Profile

Isatuximab - Immunogen/Sanofi

Alternative Names: Anti-CD38 monoclonal antibody - Sanofi; hu38SB19; SAR-650984

Latest Information Update: 04 Nov 2018

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At a glance

  • Originator ImmunoGen
  • Developer Huntsman Cancer Institute; Roche; Sanofi
  • Class Antibodies; Antineoplastics; Monoclonal antibodies
  • Mechanism of Action Apoptosis stimulants; CD38 antigen inhibitors; Immunologic cytotoxicity
  • Orphan Drug Status

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

    Yes - Multiple myeloma
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Multiple myeloma
  • Phase II T cell lymphoma
  • Phase I/II Colorectal cancer; Non-small cell lung cancer; Prostate cancer; Solid tumours
  • Discontinued Precursor cell lymphoblastic leukaemia-lymphoma

Most Recent Events

  • 29 Aug 2018 Phase-I/II clinical trials in Colorectal cancer (Metastatic disease, Combination therapy, Second-line therapy or greater) in USA (IV)
  • 31 Jul 2018 Sanofi and University of Heidelberg Medical Center plans a phase III trial for Multiple myeloma (First-line therapy, Newly diagnosed, Combination therapy) (SCT eligible patients) in September 2018 (NCT03617731)
  • 16 Jul 2018 Phase-I/II clinical trials in Solid tumours (Inoperable/Unresectable, Monotherapy, Second-line therapy or greater, Refractory metastatic disease, Recurrent) in Belgium, Netherlands (IV) (EudraCT2018-000390-67)
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