SARCLISA (isatuximab-irfc) · Sanofi
Sarclisa (isatuximab-irfc) is a CD38-directed cytolytic antibody indicated for the treatment of adult patients with multiple myeloma. It is used in combination with various therapeutic regimens for patients across different stages of the disease, including those with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. The drug is also approved for patients with relapsed or refractory disease and those who have received multiple prior therapies, including lenalidomide and a proteasome inhibitor. Sarclisa serves as a targeted immunotherapy designed to identify and eliminate malignant plasma cells.
How SARCLISA Works
Isatuximab-irfc is a monoclonal antibody that binds to the CD38 protein expressed on the surface of multiple myeloma cells. This binding triggers tumor cell death through direct apoptosis and the activation of immune effector mechanisms, such as antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity. Additionally, the drug inhibits the enzymatic activity of CD38, activates natural killer cells, and suppresses regulatory T-cells to enhance the body's immune response against the tumor. When used with pomalidomide, the combination increases direct tumor cell killing and immune-mediated activity compared to using the drug alone.
Details
- Status
- Prescription
- First Approved
- 2020-03-02
- Patent Cliff
- 2031
- Revenue
- $173M (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SARCLISA Approval History
What SARCLISA Treats
1 indicationsSARCLISA is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
SARCLISA Target & Pathway
ProTarget
A protein highly expressed on multiple myeloma cells. Anti-CD38 antibodies target and kill myeloma cells through multiple mechanisms, becoming a backbone of myeloma treatment across disease stages.
SARCLISA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in SARCLISA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SARCLISA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to SARCLISA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Sanofi's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SARCLISA FDA Label Details
Indications & Usage
FDA Label (PDF)SARCLISA is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor. 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. in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell trans...
Pro Intelligence Preview
Deep insights for SARCLISA
Revenue Insights
- • Q4-2025: $173M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.