for intravenous use Initial U.S. Approval
Darzalex (daratumumab) is a human CD38-directed monoclonal antibody used to treat multiple myeloma.
Facts about daratumumab injection
DISEASE INDICATIONS-Multiple Myeloma
MANUFACTURER-Janssen-Cilag International N.V.
MEDICINE APPROVED BY-European Medical Agency (EMA),Food and Drug Administration (FDA),Health Canada,Therapeutic Goods Administration (TGA),Medsafe (NZ)
Summary of FDA-approved use on approval date: Click Here
(see Drugs@FDA for complete indication)
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Query For daratumumab injection
Approved accessible "daratumumab injection"
DARZALEX is a CD38-directed cytolytic antibody indicated:
- in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
- as monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent.
- In November 2015, the U.S. Food and Drug Administration (FDA) approved daratumumab for treatment of multiple myeloma in patients who had received at least three prior therapies. In May 2016 daratumumab was also conditionally approved by the European Medicines Agency for treatment of multiple myeloma.
- In November 2016, the FDA approved daratumumab in combination with lenalidomide or bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
- In May 2018, the FDA expanded the approval of daratumumab for use in combination with bortezomib, melphalan and prednisone to include the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
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- FDA Approves Time-Saving Combo for R/r Multiple Myeloma
- FDA Approves Daratumumab Triplet Combo for Relapsed/Refractory Multiple Myeloma
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