AL amyloidosis

The EU has approved 1 indication of 1 drug in AL amyloidosis. None of them needs a biomarker result.
Approved indications, AL amyloidosis
DrugBiomarker requirementRegimenSettingConditions
No biomarker required1
Daratumumab
Darzalex
None
+ cyclophosphamide, bortezomib and dexamethasone
1L
None
Label wording1

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Daratumumab (Darzalex)
    DARZALEX is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic AL amyloidosis.