Pomalidomide
Pomalidomide (Imnovid (previously Pomalidomide Celgene), Bristol-Myers Squibb Pharma EEIG) has 2 EU-approved indications in 1 tumour type.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Multiple myeloma2 | |||
None | + bortezomib and dexamethasone | 2L | After at least one prior treatment regimen including lenalidomide |
None | + dexamethasone | 3L+ | After at least two prior treatment regimens, including both lenalidomide and bortezomib, and disease progression on the last therapy; Relapsed and refractory |
Full text of section 4.1 (therapeutic indications)
Imnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
Label history
34 changes to the Imnovid (previously Pomalidomide Celgene) label since 2014, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes