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On March 2, 2020, the FDA approved isatuximab (Sarclisa® (Isatuximab-irfc) for multiple myeloma. This is an anti-CD38 monoclonal antibody, similar, although 100% identical to daratumumab. Isatuximab was approved in combination with pomalidomide and dexamethasone for patients with 2 prior therapies. The combination was approved on the basis of a randomized phase 3 trial: comparing isa/pom/dex versus pom/dex. The triplet combination of IPD demonstrated a superior PFS with an improvement of approximately 6 months (~11 months versus ~5 months). The major question is whether there is an advantage of isatuximab over daratumumab. Daratumumab is also FDA approved in combination with pomalidomide/dexamethasone. In a phase 2 trial, leading to dara/pom/dex approval the PFS was also ~ 11 months. The data on the isatuximab is certainly stronger since it is a phase 3 trial. The main advantage of the isatuximab, at the present time, is slightly less infusion related reactions but with an infusion time that ultimately is FDA approved at 75 minutes-far shorter than the FDA approved infusion time for daratumumab. Of course, this difference will ultimately be moot when daratumumab is approved for SQ administration. The other advantage, at least during the first year, is slightly lower acquisition costs. However, since isatuximab is FDA approved every 2 weeks indefinitely, compared to daratumumab which goes to monthly on cycle 7, the financial costs are essentially lost after the first year of treatment. My opinion: dealer's choice. May ultimately be decided by the formulary committees?

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