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Isatuximab - ImmunoGen/Sanofi

Drug Profile

Isatuximab - ImmunoGen/Sanofi

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

Latest Information Update: 09 Jun 2024

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At a glance

  • Originator ImmunoGen
  • Developer Roche; Sanofi
  • Class Antibodies; Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action ADP-ribosyl cyclase inhibitors; Antibody-dependent cell cytotoxicity; Apoptosis stimulants; Natural killer cell stimulants; Regulatory T-lymphocyte inhibitors
  • 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

  • Marketed Multiple myeloma
  • Phase II Acute myeloid leukaemia; Colorectal cancer; Precursor cell lymphoblastic leukaemia-lymphoma; T-cell lymphoma
  • Phase I/II Lymphoma; Solid tumours; Urogenital cancer
  • Discontinued Autoimmune haemolytic anaemia; Non-small cell lung cancer; Prostate cancer; Renal transplant rejection

Most Recent Events

  • 03 Jun 2024 Efficacy and adverse event data from a phase III trial in Multiple myeloma was released by Sanofi
  • 27 May 2024 Preregistration for Multiple myeloma (Combination therapy, First-line therapy, Newly diagnosed) in European Union (IV)
  • 27 May 2024 Preregistration for Multiple myeloma (Combination therapy, First-line therapy, Newly diagnosed) in USA (IV)
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