Sanofi's Sarclisa Secures FDA Approval For First-Line Multiple Myeloma, Marking Its Third US Approval

On Saturday, the FDA approved Sanofi’s SA SNY Sarclisa (siltuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant (ASCT).

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Sarclisa is the first anti-CD38 therapy in combination with standard-of-care VRd to significantly reduce disease progression or death (by 40%) compared to VRd alone for patients with NDMM not eligible for transplant.

This decision marks the third approved indication for Sarclisa in the U.S. and the first approved indication in newly diagnosed patients.

The FDA evaluated Sarclisa for this indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.

Sarclisa is also currently approved in more than 50 countries across two indications for people with relapsed or refractory disease.

The FDA approval is based on data from the IMROZ phase 3 study.

Sarclisa-VRd followed by Sarclisa-Rd met the primary endpoint of PFS, significantly reducing the risk of recurrence or death by 40%, compared to VRd followed by Rd.

At a median follow-up of 59.7 months, the median PFS with the Sarclisa-VRd combination was not reached versus 54.3 months with VRd. The estimated PFS rate at 60 months was 63.2% for patients treated with Sarclisa-VRd versus 45.2% for VRd.

Sarclisa-VRd also met several secondary endpoints which demonstrated deep responses in this patient population:

• Approximately three-quarters (74.7%) of patients treated with Sarclisa-VRd achieved a complete response (CR) or better than 64.1% of patients taking VRd.
• More than half (55.5%) of patients treated with Sarclisa-VRd achieved MRD negative CR compared to 40.9% of patients taking VRd.

Price Action: At last check on Monday, SNY stock was down 0.50% at $57.34 during the premarket session.

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