The United States Food and Drug Administration has approved isatuximab-irfc (Sarclisa Escena) for subcutaneous injection in combination with the standard-of-care therapy in adult patients with multiple myeloma, according to a press release from Sanofi, the manufacturer of the drug.
In the press release issued by Sanofi, clinical data supporting the approval included the randomized phase 3 IRAKLIA trial, which demonstrated non-inferiority for the subcutaneous delivery method compared with the intravenous form.
“Multiple myeloma is a malignancy that often requires frequent IV infusions or manual subcutaneous injections. Treatment administration can be a cumbersome experience for patients, while also placing a strain on providers by requiring physical effort to push high-resistance syringes for several minutes,” said Sikander Ailawadhi, MD, the principal investigator of the IRAKLIA study. “The comparable efficacy observed across multiple studies and the patient-centric design of the [on-body injector] offers an opportunity to impact the patient experience while upholding Sarclisa’s consistent efficacy.”
Isatuximab-irfc is currently approved across three indications in the US, including in combination with bortezomib, lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant, Sanofi reported in the release.
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