• FDA Announcements

FDA Approved for RRMM: Sarclisa (isatuximab-irfc) + Pomalyst (Pomalidomide) and Dexamethasone (IPd)



On March 2, 2020, the Food and Drug Administration approved isatuximab-irfc (SARCLISA, sanofi-aventis U.S. LLC) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.


ICARIA-MM (NCT02990338), a multicenter, multinational, randomized, open-label, two-arm, phase 3 study in 307 patients with relapsed and refractory multiple myeloma who had received at least two prior therapies including lenalidomide and a proteasome inhibitor. Patients were randomized (1:1) to receive either isatuximab-irfc with pomalidomide and low-dose dexamethasone (Isa-Pd, 154 patients) or pomalidomide and low-dose dexamethasone (Pd, 153 patients).


 


Learn more:

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-multiple-myeloma-0



03/02/2020: FDA Approval

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761113Orig1s000ltr.pdf







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