Drug updated on 4/30/2024
| 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 (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.
- The drug is also used in combination with carfilzomib and dexamethasone, for treating adult patients suffering from relapsed or refractory multiple myeloma who have undergone 1 to 3 prior lines of therapy.
- A total of four systematic reviews/meta-analyses were reviewed which provided insights into the safety and efficacy profile of Sarclisa among other drugs used for similar indications.
- In one study, three-drug regimens based on pomalidomide and dexamethasone that included Isatuximab showed an overall response rate (ORR) of 66.3%, indicating its effectiveness against relapsed/refractory multiple myeloma; however, various adverse events were reported necessitating further studies addressing these issues.
- Another review highlighted that severe adverse events were more frequent with Isatuximab compared to some other novel agents-based therapies but it was ranked third after daratumumab and pegylated liposomal doxorubicin in terms achieving better progression-free survival rates among previously treated MM cases where lenalidomide or bortezomib was part of control arm regimen.
- For lenalidomide-refractory MM specifically, triplet therapy containing monoclonals like Sarclisa proved superior according to another network meta-analysis conducted on randomized controlled trials; this suggests potential benefits over non-monoclonals especially when considering patient subgroups resistant to certain treatments such as Lenolidamide.
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 |