Carfilzomib

Carfilzomib (Kyprolis, Amgen Europe B.V.) has 3 EU-approved indications in 1 tumour type.
Approved indications of Carfilzomib
Biomarker requirementRegimenSettingConditions
Multiple myeloma3
None
+ daratumumab and dexamethasone
2L
After at least one prior therapy
None
+ dexamethasone
2L
After at least one prior therapy
None
+ lenalidomide and dexamethasone
2L
After at least one prior therapy
Full text of section 4.1 (therapeutic indications)

Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.1).

Label history

25 changes to the Kyprolis label since 2016, 2 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes