Sanofi’s Sarclisa (isatuximab) has been approved by the US Food and Drug Administration (FDA) as part of a first-line combination treatment for adults with newly diagnosed multiple myeloma (NDMM).
The anti-CD38 therapy has been authorised alongside standard-of-care bortezomib, lenalidomide, and dexamethasone (VRd) to treat NDMM patients who are not eligible for autologous stem cell transplant.
The FDA’s decision was supported by positive results from the late-stage IMROZ trial, in which Sarclisa plus VRd followed by Sarclisa/Rd reduced the risk of disease progression or death by 40% compared to VRd followed by Rd.
Median progression-free survival (PFS) with the Sarclisa/VRd combination was not reached after a median follow up of 59.7 months versus 54.3 months with Vrd, and the estimated PFS at 60 months was 63.2% for patients treated with Sarclisa/VRd compared to 45.2% for those receiving VRd.
Benefits were also seen across the trial’s secondary endpoints, with approximately 74.7% of patients in the Sarclisa/VRd cohort achieving a complete response (CR) compared to 64.1% of those in the VRd group, and 55.5% of Sarclisa/VRd-treated patients reaching minimal residual disease negative CR compared to 40.9% of those receiving Vrd.
Multiple myeloma (MM) is the second most common haematological malignancy, with approximately 32,000 people in the US diagnosed with the disease every year. Despite available treatments, MM remains incurable and newly diagnosed patients have a five-year survival rate of about 52%.
Already approved in the US to treat certain cases of relapsed refractory MM, Sanofi’s Sarclisa is designed to bind to a specific epitope on the CD38 receptor on MM cells and induce distinct anti-tumour activity.
Brian Foard, executive vice president, head of specialty care at Sanofi, said: “With [this] approval, doctors now have an important new option at their disposal that’s been shown to slow disease progression for longer compared to the current standard-of-care for adults living with NDMM who are not eligible for transplant in the US.”
The latest authorisation comes just over a month after Sanofi shared promising results from a late-stage study of Sarclisa in NDMM patients who are eligible for transplant.