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Drug updated on 5/17/2024
Dosage Form | Injection (intravenous; 100 mg/5 mL [20 mg/mL], 500 mg/25 mL [20 mg/mL]) |
Drug Class | CD38-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
- 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 Title | Year | Source |
---|---|---|
Sarclisa (isatuximab) Prescribing Information. | 2023 | Sanofi-Aventis U.S. LLC, Bridgewater, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Multiple myeloma: EHA-ESMO clinical practice guidelines for diagnosis, treatment and follow-up. | 2021 | Annals of Oncology |
Isatuximab: nursing considerations for use in the treatment of multiple myeloma. | 2021 | Clinical Journal of Oncology Nursing |