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Ref Type
PMID
Authors
Title Darzalex (Daratumumab) FDA Drug Label
Journal
Vol
Issue
Date
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761036
Abstract Text

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Daratumumab Darzalex JNJ-54767414 CD38 Antibody 7 Darzalex (Daratumumab) is a human antibody against CD38 that induces antibody-dependent cell-mediated cytotoxicity and complement-mediated cytotoxicity against CD38-positive tumor cells (PMID: 30546360). Darzalex (Daratumumab) is FDA approved for multiple myeloma patients as a monotherapy or in combination with lenalidomide and dexamethasone, or with bortezomib and dexamethasone, or with bortezomib, melphalan, and prednisone, or with pomalidomide and dexamethasone, or with bortezomib, thalidomide and dexamethasone (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown multiple myeloma not applicable Bortezomib + Daratumumab + Dexamethasone + Thalidomide FDA approved Actionable In a Phase III trial (CASSIOPEIA) that supported FDA approval, Darzalex (daratumumab) in combination with Velcade (bortezomib), thalidomide, and dexamethasone (VTd) resulted in improved stringent complete response at 100 days post autologous stem-cell transplantation compared to VTd (29%, 157/543 vs 20%, 110/542, OR=1.60, p=0.0010) in patients with newly diagnosed multiple myeloma (PMID: 31171419; NCT02541383). detail... 31171419
Unknown unknown multiple myeloma not applicable Bortezomib + Daratumumab + Dexamethasone FDA approved Actionable In a Phase III trial (CASTOR) that supported FDA approval, the combination of Darzalex (daratumumab), Velcade (bortezomib), and Adexone (dexamethasone) resulted in a greater 12 month progression-free survival (77.5% vs 29.4%) and overall response (82.9%; 199/240 vs 63.2%; 148/234) compared to Adexone (dexamethasone) and Velcade (bortezomib) alone in relapsed or refractory multiple myeloma patients (PMID: 27557302; NCT02136134). detail... 27557302
Unknown unknown multiple myeloma not applicable Daratumumab + Dexamethasone + Lenalidomide FDA approved Actionable In a Phase III trial (POLLUX) that supported FDA approval, the combination of Darzalex (daratumumab), Adexone (dexamethasone), and Revlimid (lenalidomide) resulted in a greater 12 month progression-free survival (83.2% vs 60.1%) and overall response (92.9%; 261/281 vs 76.4%; 211/276) compared to Adexone (dexamethasone) and Revlimid (lenalidomide) alone in patients with relapsed or refractory multiple myeloma (PMID: 27705267; NCT02076009). detail... 27705267
Unknown unknown multiple myeloma not applicable Daratumumab + Dexamethasone + Pomalidomide FDA approved Actionable In a Phase I trial (EQUULEUS) that supported FDA approval, Darzalex (Daratumumab) in combination with Pomalyst (pomalidomide) and Adexone (dexamethasone) resulted in an objective response rate of 60% (61/103) in patients with relapsed or refractory multiple myeloma, with a median progression-free survival of 8.8 months and a median overall survival of 17.5 months (PMID: 28637662; NCT01998971). detail... 28637662
Unknown unknown multiple myeloma not applicable Daratumumab FDA approved Actionable In a Phase I/IIb trial (GEN501) that supported FDA approval, Darzalex (daratumumab) treatment in patients with heavily pretreated and refractory multiple myeloma resulted in an overall response rate of 36% (15/42) in the 16 mg/kg cohort, with 1 complete response and 3 very good partial responses (PMID: 26308596; NCT00574288). detail... 26308596
Unknown unknown multiple myeloma not applicable Daratumumab + Dexamethasone + Lenalidomide FDA approved Actionable In a Phase III trial (MAIA) that supported FDA approval, the combination of Darzalex (daratumumab), Adexone (dexamethasone), and Revlimid (lenalidomide) resulted in an improved rate of progression-free survival at 30 months (70.6% vs 55.6%, HR=0.56, p<0.001) compared control in newly diagnosed multiple myeloma patients ineligible for autologous stem-cell transplantation (PMID: 31141632; NCT02252172). detail... 31141632
Unknown unknown multiple myeloma not applicable Bortezomib + Daratumumab + Melphalan + Prednisone FDA approved Actionable In a Phase III trial (ALCYONE) that supported FDA approval, the combination of Darzalex (daratumumab), Velcade (bortezomib), Alkeran (melphalan), and Adasone (prednisone) resulted in improved 18-month progression-free survival rate (71.6% vs 50.2%, HR=0.50, p<0.001) and overall response rate (90.9% vs 73.9%, p<0.001) compared to control in newly diagnosed multiple myeloma patients ineligible for autologous stem-cell transplantation (PMID: 29231133; NCT02195479). detail... 29231133