Isatuximab-irfc

(Sarclisa®)

Sarclisa®

Drug updated on 5/17/2024

Dosage FormInjection (intravenous; 100 mg/5 mL [20 mg/mL], 500 mg/25 mL [20 mg/mL])
Drug ClassCD38-directed cytolytic antibodies
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
  • Indicated in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.

Summary
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  • Isatuximab-irfc (Sarclisa) is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Additionally, it is used in combination with carfilzomib and dexamethasone for treating adults with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.
  • The information was derived from six systematic reviews/meta-analyses focusing on Sarclisa (isatuximab-irfc).
  • In terms of safety, isatuximab has been associated with higher rates of hematologic adverse events such as thrombocytopenia and neutropenia, along with non-hematologic adverse events like infections, dyspnea, diarrhea, pyrexia, and back pain compared to treatments excluding anti-CD38 monoclonal antibodies.
  • Regarding effectiveness comparison against other drugs, isatuximab showed improvement in progression-free survival for multiple myeloma patients; it significantly improved PFS and overall survival when combined with immunomodulatory drugs or proteasome inhibitors; demonstrated a solid overall response rate against other triplet therapies based on pomalidomide and dexamethasone; and ranked high among novel agents used in relapsed or refractory multiple myeloma treatments according to network meta-analysis results.
  • The drug shows promising results as monotherapy but even better outcomes when used in combination therapies, suggesting its pivotal effectiveness, especially useful for tackling resistant forms of multiple myeloma.
  • Population types considered include those having high-risk genetic profiles like +1q abnormalities cases refractory to lenalidomide, making it an essential component of future multiple myeloma therapy paradigms due to its efficacy across a broad spectrum of populations.

Product Monograph / Prescribing Information

Document TitleYearSource
Sarclisa (isatuximab) Prescribing Information.2023Sanofi-Aventis U.S. LLC, Bridgewater, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines