Background
Isatuximab-irfc (Sarclisa) is a CD38-directed cytolytic antibody approved by the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma. It is designed to bind to CD38 expressed on the surface of hematopoietic and tumor cells, including multiple myeloma cells, inducing apoptosis and activating immune effector mechanisms.
FDA-Approved Indications
- Multiple Myeloma Treatment: Sarclisa is approved for use in combination with pomalidomide and dexamethasone for adult patients who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.
- Relapsed or Refractory Multiple Myeloma: It is also approved for use in combination with carfilzomib and dexamethasone for adult patients who have received one to three prior lines of therapy.
Clinical Trials and Effectiveness
- ICARIA-MM Study: A phase 3 study demonstrated that Sarclisa, in combination with pomalidomide and dexamethasone, significantly improved progression-free survival compared to pomalidomide and dexamethasone alone in patients with relapsed and refractory multiple myeloma.
- IKEMA Study: This phase 3 study showed that adding Sarclisa to carfilzomib and dexamethasone reduced the risk of disease progression or death by 45% compared to carfilzomib with dexamethasone alone.
Dosage and Administration
Sarclisa is administered as an intravenous infusion. The recommended dose is 10 mg/kg actual body weight, with treatment cycles consisting of a 28-day period. Treatment is repeated every week for 4 weeks, followed by every 2 weeks until disease progression or unacceptable toxicity.
Safety Profile
The most common adverse reactions include infusion reactions, upper respiratory tract infections, and diarrhea. Serious adverse reactions observed in more than 5% of patients include pneumonia and upper respiratory tract infections.
Conclusion
Isatuximab-irfc (Sarclisa) represents a significant advancement in the treatment of multiple myeloma, offering a new therapeutic option for patients who have undergone prior treatments. Its approval is based on robust clinical trial data demonstrating improved progression-free survival and a manageable safety profile.
