- FDA Announcements
FDA Approved for RRMM: Sarclisa (isatuximab-irfc) + Kyprolis (Carfilzomib) and Dexamethasone (IKd)
On March 31, 2021, the Food and Drug Administration approved isatuximab-irfc (Sarclisa, sanofi-aventis U.S. LLC) in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
The efficacy and safety of isatuximab-irfc in combination with carfilzomib and dexamethasone was evaluated in IKEMA (NCT03275285), a multicenter, multinational, randomized, open-label, two-arm, phase 3 trial in patients with relapsed and/or refractory multiple myeloma who had received one to three prior lines of therapy. The trial randomized 302 patients (3:2) to receive isatuximab-irfc with carfilzomib and dexamethasone (Isa-Kd) or carfilzomib and dexamethasone (Kd).
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03/31/2021: FDA Approval