Isatuximab: First Approval
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ADISINSIGHT REPORT
Isatuximab: First Approval Sohita Dhillon1
© Springer Nature Switzerland AG 2020
Abstract Isatuximab (isatuximab-irfc; S arclisa®) is an IgG1 monoclonal antibody that binds to the glycoprotein CD38 expressed on the surface of haematopoietic and tumour cells. It is being developed by Sanofi, under a license from Immunogen, for the treatment of haematological malignancies. In March 2020, intravenous isatuximab (in combination with pomalidomide and dexamethasone) was approved in the USA for the treatment of adult patients with multiple myeloma who have received ≥ 2 prior therapies, including lenalidomide and a proteasome inhibitor. Isatuximab has also received a positive opinion in the EU for the treatment of relapsed and refractory multiple myeloma. This article summarizes the milestones in the development of isatuximab leading to the first approval in the USA. Isatuximab (Sarclisa®): Key points A CD38-directed cytolytic antibody is being developed by Sanofi for the treatment of multiple myeloma and haematological malignancies Received its first approval on 2 March 2020 in the USA Approved, in combination with pomalidomide and dexamethasone, for the treatment of adults with multiple myeloma who have received ≥ 2 prior therapies, including lenalidomide and a proteasome inhibitor
1 Introduction Isatuximab (isatuximab-irfc; S arclisa®) is an anti-CD38 monoclonal antibody being developed by Sanofi, under license from Immunogen, for the treatment of multiple Enhanced material for this AdisInsight Report can be found at https://doi.org/10.6084/m9.figshare.12101598. This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through preclinical and clinical studies to market launch and beyond. * Sohita Dhillon [email protected] 1
myeloma and haematological malignancies. CD38 is a multifunctional cell surface protein with receptor and enzyme functions. It is expressed at relatively low levels on normal lymphoid and myeloid cells and in some tissues of nonhematopoietic origin, but is highly and uniformly expressed on multiple myeloma cells [1, 2]. Isatuximab (in combination with pomalidomide and dexamethasone) received its first approval in the USA [3] for the treatment of adults with multiple myeloma who have received ≥ 2 prior therapies including lenalidomide and a proteasome inhibitor [4]. The recommended dosage of isatuximab is 10 mg/kg bodyweight administered as an intravenous infusion in combination with pomalidomide and dexamethasone. Prior to the infusion of isatuximab, patients should be premedicated with dexamethasone, acetaminophen (paracetamol), H2 antagonists and diphenhydramine [4]. Isatuximab has also received a positive opinion in the EU for the treatment of adults with relapsed and refractory multiple myeloma (RRMM) who have received ≥ 2 prior therapies, including lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on the last [5].
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