Isatuximab
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Multiple myeloma4 | |||
None | + bortezomib, lenalidomide, and dexamethasone | 1L | Transplant-ineligible |
None | + bortezomib, lenalidomide, and dexamethasone | Induction | Transplant-eligible |
None | + carfilzomib and dexamethasone | 2L | After at least one prior therapy |
None | + pomalidomide and dexamethasone | 3L+ | After at least two prior therapies including lenalidomide and a proteasome inhibitor, with disease progression on the last therapy |
Full text of section 4.1 (therapeutic indications)
Isatuximab is indicated: - in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. - in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.1). - in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. - in combination with bortezomib, lenalidomide, and dexamethasone, for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
Label history
18 changes to the Sarclisa label since 2021, 3 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes