Shots:
- The MHLW has approved Sarclisa (isatuximab; SC) + SoC for MM, while regulatory filing for the CirCLIQ on-body injector (OBI), based on the enFuse platform & submitted by Enable Injections, is under review; filing for both OBI & SC manual injection is under FDA review
- Approval was based on the P-III (IRAKLIA) study in R/R MM, which showed non-inferiority of the SC formulation vs IV, as well as supportive studies
- Additionally, in IRAKLIA, SC Sarclisa delivered via Enable Injections’ enFuse OBI in combination with pomalidomide & dexamethasone achieved a 71.1% ORR vs 70.5% with IV Sarclisa-Pd, meeting the non-inferiority EP in adults with R/R MM who had received ≥1L of treatment
Ref: Globenewswire | Image: Sanofi | Press Release
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