The FDA has granted approval to Sanofi’s Sarclisa (siltuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment option for adult patients newly diagnosed with multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant (ASCT). This marks a significant milestone in the fight against this challenging cancer.
Sarclisa, an anti-CD38 therapy, is the first of its kind to demonstrate a significant reduction in disease progression or death (by 40%) when combined with standard-of-care VRd, compared to VRd alone, for patients with NDMM ineligible for transplant. This approval is the third for Sarclisa in the U.S., and the first for newly diagnosed patients.
The FDA’s decision to grant Priority Review for this indication underscores the potential of Sarclisa to improve treatment outcomes for patients with NDMM. This designation is reserved for medicines that hold the promise of offering significant improvements in efficacy or safety in treating serious conditions.
The approval is based on data from the IMROZ phase 3 study, which showed that Sarclisa-VRd followed by Sarclisa-Rd met the primary endpoint of progression-free survival (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.
Beyond the primary endpoint, Sarclisa-VRd also achieved several secondary endpoints, demonstrating deep responses in this patient population:
* Approximately three-quarters (74.7%) of patients treated with Sarclisa-VRd achieved a complete response (CR) or better, compared to 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.
Sarclisa is currently approved in over 50 countries across two indications for people with relapsed or refractory disease. This latest approval expands its reach and provides a new treatment option for patients with NDMM.
As of Monday’s premarket session, SNY stock was down 0.50% at $57.34.
