Drugs

Subcutaneous Sarclisa with On-Body Injector Approved

FDA has approved a new subcutaneous formulation of Sanofi's anti-CD38 monoclonal antibody Sarclisa (isatuximab-irfc), allowing the therapy to be administered using an on-body injector across all currently approved U.S. indications for the intravenous version of the drug.

The newly approved product, marketed as Sarclisa Escena, is the first anticancer therapy approved for administration through an on-body injector and the first multiple myeloma treatment in the U.S. that can be delivered either through an automated wearable injector or by manual subcutaneous injection, according to Sanofi.

The approval covers all existing indications for intravenous Sarclisa, including newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplantation and patients with relapsed or refractory disease receiving approved combination regimens.

FDA’s decision was supported by data from the pivotal Phase 3 IRAKLIA trial, which demonstrated that subcutaneous Sarclisa administered through an on-body injector achieved efficacy, pharmacokinetics and safety comparable to intravenous infusion while substantially reducing treatment administration time, according to the company.

In the randomized non-inferiority study involving patients with relapsed or refractory multiple myeloma, the subcutaneous formulation combined with pomalidomide and dexamethasone produced an objective response rate of 71.1%, compared with 70.5% for the intravenous regimen, meeting the study's primary endpoint for non-inferiority, it says.

The wearable injector, developed by Enable Injections using its enFuse platform, is designed to deliver large-volume biologic therapies subcutaneously through a short, retractable 30-gauge needle after activation with the push of a button.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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