Drugs

FDA extends review for Sanofi’s subcutaneous Sarclisa

FDA has extended by three months its review of a Sanofi BLA for a subcutaneous formulation of Sarclisa (isatuximab-irfc) for use in combination with standard-of-care regimens for patients with multiple myeloma across all indications currently approved for the drug’s intravenous (IV) formulation. The revised target action date is now 7/23.

Sanofi said it is continuing to work with the FDA during the extended review period. The company did not specify the reason for the delay, which is a common regulatory step that can occur when additional time is needed to assess data or review submissions. Sanofi noted the treatment would be the first anticancer drug delivered via an on-body injector, a device designed to administer medication over time without requiring a traditional infusion.

The regulatory update in the U.S. follows progress in Europe. In March, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of the subcutaneous formulation, including both on-body injector and manual injection options. A final decision from European regulators is expected in the coming months.

Sarclisa, a CD38-targeting monoclonal antibody, is already approved in nearly 60 countries for multiple myeloma, including use in both newly diagnosed patients and those with relapsed or refractory disease. According to Sanofi, more than 60,000 patients worldwide have been treated with Sarclisa-based regimens.

The potential shift to a subcutaneous option reflects a broader trend in oncology toward more convenient, less resource-intensive drug delivery methods, particularly for therapies traditionally administered intravenously.

A subcutaneous Sarclisa would compete directly with Johnson & Johnson’s blockbuster Darzalex Faspro (daratumumab and hyaluronidase-fihj). While both drugs are CD38-directed monoclonal antibodies used to treat various stages of multiple myeloma, they differ in their delivery methods and clinical history. Subcutaneous Darzalex Faspro has a significant head start, having been FDA-approved since 2020.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome