Sanofi’s Sarclisa (isatuximab-irfc) Receives the US FDA’s Approval for Relapsed Refractory Multiple Myeloma

Shots:

• The approval is based on P-III ICARIA-MM study Sarclisa (IV, 10mg/kg) + pomalidomide + dexamethasone (pom-dex) vs pom-dex as monothx. in patients with RRMM, prior treated with at least two therapies including lenalidomide and a proteasome inhibitor
• The P-III ICARIA-MM study results: improvement in PFS (11.53 vs 6.47); improvement in ORR (60.4% vs 35.3%)
• Sarclisa is mAb targeting CD38 receptor on MM cells, act by inducing apoptosis & immunomodulatory activity and has received FDA & EMA’s ODD with its anticipated availability in the US soon

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