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†In combination with pomalidomide and dexamethasone, for the treatment of relapsed and refractory multiple myeloma, in individuals:
- who have previously received at least two lines of therapies including lenalidomide and a proteasome inhibitor; and
- whose ECOG performance status is 0-2.
The maximum duration of each authorization is 4 months.
When requesting continued treatment, the physician must provide proof of a beneficial clinical effect based on the absence of disease progression, as defined by the criteria of the International Myeloma Working Group.
It should be noted that isatuximab is not authorized following failure of an antibody targeting the CD38 protein, if this was administered for the treatment of multiple myeloma.
It should also be noted that, in the absence of disease progression, the addition of isatuximab is authorized in individuals who have begun treatment with a combination of pomalidomide and dexamethasone, provided they meet the requirements of this indication.
In combination with carfilzomib and dexamethasone, for the treatment of relapsed or refractory multiple myeloma in individuals:
- who have already received at least one intention to treat; and
- with an ECOG performance status of 0-2.
The maximum duration of each authorization is 4 months.
When requesting continued treatment, the physician must provide proof of a beneficial clinical effect based on the absence of disease progression, as defined by the criteria of the International Myeloma Working Group.
It should be noted that isatuximab is not authorized following failure of an antibody targeting the CD38 protein, if this was administered for the treatment of multiple myeloma.
It should also be noted that, in the absence of disease progression, the addition of isatuximab is authorized in individuals who have begun treatment with a combination of carfilzomib and dexamethasone, provided they meet the requirements of this indication.
