Elotuzumab
Elotuzumab (Empliciti, Bristol-Myers Squibb Pharma EEIG) has 2 EU-approved indications in 1 tumour type.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Multiple myeloma2 | |||
None | + lenalidomide 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)
Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy (see sections 4.2 and 5.1). Empliciti 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 (see sections 4.2 and 5.1).
Label history
12 changes to the Empliciti label since 2017, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes