SC Isatuximab Approval Reflects Evolution of Patient-Centered Myeloma Care

Joseph Mikhael, MD, MEd, professor in the Applied Cancer Research and Drug Discovery Division at the Translational Genomics Research Institute, discusses the clinical significance of the FDA approval of subcutaneous (SC) isatuximab(Sarclisa Escena), reflecting on how SC administration has benefited the landscape of multiple myeloma care. From leading the first-in-human study of isatuximab to the present day, Mikhael says he has witnessed the drug’s therapeutic evolution from an intravenous (IV) formulation to a rapid, SC option with a unique on-body injector for convenient administration.

Myeloma therapies are characterized by their long duration, with patients frequently undergoing clinic-administered treatment over months or years. Transitioning from IV to SC formulations represents a massive step forward because it drastically reduces the time patients must spend in the clinic. Additionally, subcutaneous delivery eliminates the ongoing need for intravenous access, making the surgical placement of ports less clinically necessary.

Beyond convenience, the SC route offers substantial safety and tolerability advantages. This method of administration results in fewer infusion-related reactions and adverse events. Consequently, it reduces the need for heavy premedications, which carry their own adverse events and require additional clinic time to administer. SC formulations also streamline the preparation process because they do not require complex mixing and weight-based adjustments. This simplification minimizes compounding errors and ensures that patients receive their effective doses reliably.

Although the intravenous infusion of isatuximab was already relatively short, typically lasting between an hour and 75 minutes, the new subcutaneous formulation compresses this timeline to under 15 minutes. This rapid delivery is achieved using either a direct subcutaneous push or a novel on-body injector that further reduces the amount of labor by an oncology nurse. By removing the barrier of IV-only administration for this anti-CD38 antibody, this approval ensures that isatuximab can be delivered more quickly, effectively, and in a patient-centered manner.