The FDA has approved a new drug called Sarclisa (isatuximab) for adults with multiple myeloma, a type of blood cancer. Sarclisa is a targeted antibody that helps the immune system attack cancer cells. It is approved for use in three different combinations with other medicines. One combination is for patients who have already tried at least two other treatments. Another is for patients whose cancer has come back after one to three prior treatments. The third is for newly diagnosed patients who cannot have a stem cell transplant. This approval means more options are available for people at different stages of multiple myeloma. However, every patient is different. The best treatment plan depends on your specific health history and the stage of your disease. Talk to your doctor about whether Sarclisa might be right for you. Your doctor can explain the possible benefits and risks based on your situation.
FDA approved Sarclisa (isatuximab) for Multiple Myeloma in Three CombinationsFDA approved Sarclisa for multiple myeloma in three drug combinations.
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The FDA has approved Sarclisa (isatuximab), a CD38-directed cytolytic antibody, for the treatment of adult patients with multiple myeloma in three distinct combination regimens. The approval covers use with pomalidomide and dexamethasone for patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor; with carfilzomib and dexamethasone for relapsed or refractory multiple myeloma after one to three prior lines of therapy; and with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients who are not eligible for autologous stem cell transplant. This approval expands treatment options for multiple myeloma across different stages of the disease, offering a targeted approach for patients with varying treatment histories. Clinicians should note the specific dosing schedules and premedication requirements outlined in the prescribing information.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Sarclisa is a CD38-directed cytolytic antibody. It binds to CD38 on multiple myeloma cells, inducing apoptosis through immune effector mechanisms such as antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity.
Sarclisa is indicated in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor. It is also indicated in combination with carfilzomib and dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. Additionally, it is indicated in combination with bortezomib, lenalidomide, and dexamethasone for adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).
The recommended dose of Sarclisa is 10 mg/kg actual body weight administered as an intravenous infusion. Premedication with dexamethasone, acetaminophen, H2 antagonists, and diphenhydramine is required. Dosing schedules vary by combination: with pomalidomide/dexamethasone or carfilzomib/dexamethasone, weekly for cycle 1 then every 2 weeks; with bortezomib/lenalidomide/dexamethasone, cycle 1 (42-day) weekly, cycles 2-4 every 2 weeks, cycles 5-17 every 2 weeks, then every 4 weeks. No dose reduction is recommended; dose delay may be required for hematological toxicity.
Trial data not available in label.
Infusion-related reactions may occur; administer premedications and monitor during infusion. Antimicrobial prophylaxis (antibacterial and antiviral) should be considered. Hematological toxicity may require dose delay. For complete safety information, refer to the full prescribing information.
Sarclisa provides a CD38-directed therapy option for multiple myeloma across different treatment settings: as a later-line option with pomalidomide/dexamethasone, as a second- or third-line option with carfilzomib/dexamethasone, and as a frontline option for transplant-ineligible patients with bortezomib/lenalidomide/dexamethasone.
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