The new SARCLISA J-code J9227 is now available, effective October 1, 2020, to be used for reimbursement claims. Refer to the Billing and Coding Guide on the Resources page for additional details. MAT-US-2018558-v1.0-08/2020

Trial Results

Demonstrated Efficacy With SARCLISA + Pd vs Pd Alone

PFS ORR

SARCLISA + Pd extended median PFS to ~1 year1

Superior PFS with SARCLISA + Pd vs Pd alone1

The median duration of treatment was 41 weeks with SARCLISA + Pd vs 24 weeks with Pd. 1

At a median follow-up time of 11.6 months, 43 patients (27.9%) receiving SARCLISA + Pd and 56 patients (36.6%) receiving Pd had died. Median OS was not reached for either treatment group at interim analysis. The OS results at interim analysis did not reach statistical significance. 1

ORR: SARCLISA + Pd (95% CI: 52.2%, 68.2%), Pd (95% CI: 27.8%, 43.4%). 95% CI estimated using the Clopper-Pearson method.

Median time to first response was 35 days with SARCLISA
+ Pd vs 58 days with Pd alone among responders1

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)

Category 1 recommendation for isatuximab-irfc (SARCLISA)

Isatuximab-irfc (SARCLISA) is the only mAb in combination with pomalidomide and dexamethasone included as an NCCN Guidelines® Category 1 recommended regimen for previously treated multiple myeloma.2

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Expert review Join Joseph Mikhael, MD, and Kenneth Shain, MD, PhD, as they discuss the trial results for SARCLISA
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CR=complete response; mAb=monoclonal antibody; NCCN=National Comprehensive Cancer Network; ORR=overall response rate; OS=overall survival; Pd=pomalidomide and dexamethasone; PFS=progression-free survival; PR=partial response; sCR=stringent complete response; VGPR=very good partial response.

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References: 1. SARCLISA [prescribing information]. Bridgewater, NJ: sanofi-aventis U.S. LLC. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.4.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed June 16, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org.