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Reimbursement status:
Reimbursement with restrictions

Cancer: Multiple myeloma and plasma cell neoplasms

Indication:

Daratumumab is indicated: - in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. - as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. - in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Reimbursement information:

EPAR/SmPC

Drug programme

Details

ATC category :
L01XC
L01XC Monoclonal antibodies
EMA approval status :
Approved
EMA approval date :
2016-05-20
EMA conditional? :
No
EMA orphan? :
Yes
EMA biological? :
Yes