Subcutaneous Isatuximab Approval Expands Options in Multiple Myeloma

On July 9, 2026, the FDA approved subcutaneous isatuximab-irfc (Sarclisa Escena), administered via an on-body injector or manual subcutaneous injection, across all previously approved isatuximab indications in multiple myeloma.The agent was approved in combination with pomalidomide (Pomalyst) and dexamethasone in multiple myeloma after at least 1 prior therapy including lenalidomide (Revlimid) and a proteasome inhibitor; carfilzomib (Kyprolis) and dexamethasone in relapsed/refractory disease after from 1 to 3 prior lines of therapy; and with bortezomib (Velcade), lenalidomide, and dexamethasone (Isa-VRd) in transplant-ineligible newly diagnosed disease not eligible for an autologous stem cell transplant. Isatuximab was previously available only as an intravenous formulation.

Sikander Ailawadhi, MD, a professor of medicine and leader of the multiple myeloma group at Mayo Clinic in Jacksonville, Florida, spoke with CancerNetwork® about what the approval means for how patients can receive anti-CD38 monoclonal antibody therapy. He noted that the newly approved subcutaneous formulation of isatuximab will introduce “many more options” for patients to receive anti-CD38 monoclonal antibodies as part of their treatment for multiple myeloma.

Transcript:

CancerNetwork: What does the FDA approval of subcutaneous isatuximab plus standard-of-care regimens mean for different patient populations with multiple myeloma?

Ailawadhi: This is an FDA approval that just came out based on data from different trials…that led to the approval of subcutaneous isatuximab, administered through either the on-body injector or manual subcutaneous administration. Both are approved across all the indications for [intravenous] isatuximab. Previously, isatuximab was available only as an intravenous formulation. It is available in 3 regimens: isatuximab with pomalidomide and dexamethasone; isatuximab with carfilzomib and dexamethasone—both for relapsed/refractory disease—and isatuximab with bortezomib, lenalidomide, and dexamethasone—the Isa-VRd regimen—in newly diagnosed patients.

The approval has now brought the option of subcutaneous isatuximab, but more importantly, in my mind, the subcutaneous administration using the on-body injector across all its approved regimens. The importance of that, from a patient standpoint, is that patients will now have many more options for how to receive an anti-CD38 monoclonal antibody for their treatment.

Reference

FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications. News release. FDA. July 9, 2026. Accessed July 13, 2026. https://tinyurl.com/4cccdbpn