According to a September 20, 2024, press release, the U.S. Food and Drug Administration (FDA) has "approved isatuximab-irfc (Sarclisa, Sanofi-Aventis U.S. LLC) with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT)."
This approval was based on results of the phase III IMROZ clinical trial (NCT03319667). The IMROZ trial showed that when Sarclisa is added to Velcade (bortezomib), Revlimid (lenalidomide), and dexamethasone (VRd) in newly diagnosed multiple myeloma (NDMM) patients who are not eligible for autologous stem cell transplant (ASCT), these patients experienced longer progression-free survival (PFS) compared to those who received VRd-alone. (VRd is the standard of care in newly diagnosed patients who cannot undergo ASCT.)
The IMROZ trial is an open-label, randomized, active-controlled phase III trial in NDMM not eligible for ASCT. For this trial, patients were 80 years of age or younger. During the trial, 446 patients were "randomized to receive either Sarclisa (isatuximab-irfc) with Velcade (bortezomib), Revlimid (lenalidomide), and dexamethasone (Isa-VRd) or Velcade (bortezomib), Revlimid (lenalidomide) and dexamethasone (VRd)."
An independent review committee assessed PFS's efficacy using the International Myeloma Working Group (IMWG) criteria. Here were the results for the basis of this approval;:
- An improvement in PFS in the Isa-VRD arm with a 40% reduction of disease progression or death
- The median PFS was not attained in the Isa-VRd arm.
- PFS was 54.3 months in the VRd arm.
According to the FDA press release, "the most common adverse reactions (≥20%) were upper respiratory tract infection, diarrhea, fatigue, peripheral sensory neuropathy, pneumonia, musculoskeletal pain, cataracts, constipation, peripheral edema, rash, infusion-related reaction, insomnia, and COVID-19 infection."
The recommended dosage of Sarclisa (isatuximab-irfc) is 10mg/kg actual body weight. It is given by an intravenous infusion.
This FDA approval is the third approved indication of Sarclisa (isatuximab-irfc) in the U.S. and the first approved indication in NDMM patients. Note: The suffix -irfc is in accordance with nonproprietary naming of biological products guidance for industry issued by the U.S. FDA.
Read the full press release from the button below to learn more.