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Isatuximab - Sanofi

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Drug Profile

Isatuximab - Sanofi

Alternative Names: Anti-CD38 monoclonal antibody - Sanofi; Hu 38SB19; Isatuximab-irfc - Sanofi; SAR-650984; Sarclisa

Latest Information Update: 09 Oct 2024

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At a glance

  • Originator ImmunoGen
  • Developer Roche; Sanofi
  • Class Antibodies; Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; CD38 antigen inhibitors; Natural killer cell stimulants; T lymphocyte stimulants
  • 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 I/II Urogenital cancer
  • Discontinued Acute myeloid leukaemia; Autoimmune haemolytic anaemia; Colorectal cancer; Lymphoma; Non-small cell lung cancer; Precursor cell lymphoblastic leukaemia-lymphoma; Prostate cancer; Renal transplant rejection; Solid tumours; T-cell lymphoma

Most Recent Events

  • 09 Oct 2024 Discontinued - Phase-I/II for Colorectal cancer (Combination therapy, Metastatic disease, Second-line therapy or greater) in Switzerland, United Kingdom, South Korea, Australia, France (IV) prior to October 2024 (Sanofi pipeline, October 2024)
  • 09 Oct 2024 Discontinued - Phase-I/II for Colorectal cancer (Combination therapy, Metastatic disease, Second-line therapy or greater) in USA (IV)
  • 09 Oct 2024 Discontinued - Phase-I/II for Lymphoma (Combination therapy, In adolescents, In children, Second-line therapy or greater, In adults) in Taiwan, Spain, Portugal, Netherlands, South Korea, Italy, France (IV) prior to October 2024 (Sanofi pipeline, October 2024)

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