FDA Approves Sarclisa With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma

The FDA has approved isatuximab-irfc (Sarclisa, Sanofi-Aventis) with bortezomib, lenalidomide and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for an autologous stem cell transplant (ASCT).

Efficacy was evaluated in IMROZ (ClinicalTrials.gov. Identifier: NCT03319667), an open-label, randomized, active-controlled, phase 3 trial in patients with newly diagnosed multiple myeloma who were not eligible for ASCT. Enrollment was limited to patients 80 years of age