Daratumumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2015
- First approval year
- 2015
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Daratumumab
- daratumumab component of darzalex faspro
- Daratumumab component of darzalex faspro
- darzalex
- Darzalex
- 3003 005
- 3003-005
- ct p44 daratumumab
- CT-P44(Daratumumab)
- daratumumab
- Daratumumab
- DARATUMUMAB
- DARATUMUMAB (DARZALEX®)
- Daratumumab (Intravenously)
- Daratumumab (Part 2)
- Daratumumab (Subcutaneously)
- daratumumab [INN]
- DARATUMUMAB [JAN]
- DARATUMUMAB [MI]
- DARATUMUMAB [PURPLE BOOK CDER]
- DARATUMUMAB [USAN]
- Daratumumab [WHO-DD]
- daratumumab fihj
- Daratumumab Injection
- Daratumumab Injection (Subcutaneous Injection)
- daratumumab inn
- Daratumumab IV
- daratumumab jan
- daratumumab mi
- daratumumab purple book cder
And 19 more, listed on the interactive page.
- ATC classification codes
- L01FC01
Sources for recorded values
- CAS registry numbers
- 945721-28-8
- ChEMBL ID
- CHEMBL1743007
- FDA ingredient codes (UNII)
- 4Z63YK6E0E
- 1721947
- 2375130
- Applicant
- JANSSEN BIOTECH
- Approval date
- 16 Nov 2015
- Application number
- BLA761036
- Status
- Authorised
- Status date
- 20 May 2016
- Authorisation date
- 20 May 2016
- Approved indications
- Multiple Myeloma Darzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma. in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. 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. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5.1). in 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. Smouldering multiple myeloma Darzalex as monotherapy is indicated for the treatment of adult patients with smouldering multiple myeloma at high risk of developing multiple myeloma. Light chain (AL) amyloidosis Darzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis. Darzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. 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. 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.
- Product number
- EMEA/H/C/004077
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- Yes
- Exceptional circumstances
- No
Therapeutic areas
- Multiple Myeloma
European medicines record
- Patents
- 0
- Designations
- 7
- Earliest recorded loss of exclusivity
- 23 Jun 2031
- First in class
- Yes
- Fast track
- Yes
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- Yes
- Availability
- Prescription only
- Pharmacology name
- daratumumab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Antagonist
- Action type
- Antagonist
- Target
- CD38
- Gene symbol
- CD38
- Protein identifier
- P28907
- Median affinity
- 8.22
- Affinity units
- pKd
- Primary target
- Yes
- Mechanism
- Lymphocyte differentiation antigen CD38 inhibitor
- Action type
- Inhibitor
- Target
- ADP-ribosyl cyclase/cyclic ADP-ribose hydrolase 1
- Protein identifier
- P28907
Open Targets mechanisms
- Mechanism
- Lymphocyte differentiation antigen CD38 inhibitor
- Action type
- Inhibitor
- Target
- ADP-ribosyl cyclase/cyclic ADP-ribose hydrolase 1
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Hodgkin Disease
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000183
- Subject identifier
- D006689
- Condition
- Myelodysplastic Syndromes
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000198
- Subject identifier
- D009190
- Condition
- Paraproteinemias
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000203
- Subject identifier
- D010265
- Condition
- Leukemia, Biphenotypic, Acute
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000209
- Subject identifier
- D015456
- Condition
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000220
- Subject identifier
- D054198
- Condition
- Leukemia, Myeloid, Acute
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000222
- Subject identifier
- D015470
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0000349
- Subject identifier
- D002292
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Glioblastoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000519
- Subject identifier
- D005909
- Condition
- Immune System Diseases
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000540
- Subject identifier
- D007154
- Condition
- Leukemia
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000565
- Subject identifier
- D007938
- Condition
- Lymphoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000673
- Subject identifier
- D011471
- Condition
- Multiple Myeloma
- Highest recorded phase
- 4
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Lymphoma, T-Cell, Cutaneous
- Highest recorded phase
- 1
- Condition identifier
- EFO:0002913
- Subject identifier
- D016410
- Condition
- Carcinoma, Non-Small-Cell Lung
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003060
- Subject identifier
- D002289
- Condition
- Smoldering Multiple Myeloma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003073
- Subject identifier
- D000075122
- Condition
- Nephrotic Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004255
- Subject identifier
- D009404
- Condition
- Neuromyelitis Optica
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004256
- Subject identifier
- D009471
- Condition
- Leukemia, Lymphoid
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004289
- Subject identifier
- D007945
- Condition
- Graft vs Host Disease
- Highest recorded phase
- 1
- Condition identifier
- EFO:0004599
- Subject identifier
- D006086
- Condition
- Anemia, Hemolytic
- Highest recorded phase
- 1
- Condition identifier
- EFO:0005558
- Subject identifier
- D000743
- Condition
- Lupus Nephritis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005761
- Subject identifier
- D008181
And 21 more, listed on the interactive page.
- Condition identifier
- EFO_0000095
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000198
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000200
- Condition identifier
- EFO_0000203
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000209
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000220
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000222
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000403
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000519
- Condition identifier
- EFO_0000540
- Condition identifier
- EFO_0000551
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000565
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0001378
- Condition identifier
- EFO_0003060
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003073
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004256
- Condition identifier
- EFO_0004289
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004599
- Condition identifier
- EFO_0005558
- Highest recorded phase
- 1
- Condition identifier
- EFO_0005761
- Highest recorded phase
- 2
- Condition identifier
- EFO_0006475
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007160
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007355
- Highest recorded phase
- 2
And 79 more, listed on the interactive page.
- Event
- coombs indirect test positive
- Reports
- 25
- Reporting signal score
- 121.262
- Event
- cytomegalovirus infection
- Reports
- 93
- Reporting signal score
- 116.625
- Event
- cytomegalovirus infection reactivation
- Reports
- 46
- Reporting signal score
- 110.73
- Event
- cytopenia
- Reports
- 72
- Reporting signal score
- 104.94
- Event
- disease progression
- Reports
- 223
- Reporting signal score
- 141.829
- Event
- drug interaction
- Reports
- 3
- Reporting signal score
- 103.719
- Event
- febrile neutropenia
- Reports
- 202
- Reporting signal score
- 148.97
- Event
- headache
- Reports
- 67
- Reporting signal score
- 110.771
- Event
- hypogammaglobulinaemia
- Reports
- 56
- Reporting signal score
- 98.7412
- Event
- infusion related reaction
- Reports
- 1,201
- Reporting signal score
- 3,023.6
- Event
- neuropathy peripheral
- Reports
- 293
- Reporting signal score
- 245.99
- Event
- neutropenia
- Reports
- 394
- Reporting signal score
- 261.878
- Event
- neutrophil count decreased
- Reports
- 162
- Reporting signal score
- 156.417
- Event
- plasma cell myeloma
- Reports
- 408
- Reporting signal score
- 862.448
- Event
- plasma cell myeloma recurrent
- Reports
- 49
- Reporting signal score
- 104.287
- Event
- plasmacytoma
- Reports
- 44
- Reporting signal score
- 112.846
- Event
- platelet count decreased
- Reports
- 226
- Reporting signal score
- 120.351
- Event
- pneumonia
- Reports
- 518
- Reporting signal score
- 288.877
- Event
- polyneuropathy
- Reports
- 113
- Reporting signal score
- 185.835
- Event
- thrombocytopenia
- Reports
- 384
- Reporting signal score
- 280.264
- Event
- tumour lysis syndrome
- Reports
- 64
- Reporting signal score
- 103.49
- NCT00574288
- NCT01415882
- NCT01592370
- NCT01615029
- NCT01620879
- NCT01665794
- NCT01946477
- NCT01985126
- NCT01998971
- NCT02076009
- NCT02116569
- NCT02136134
- NCT02195479
- NCT02252172
- NCT02316106
- NCT02343042
- NCT02419118
- NCT02431208
- NCT02477891
- NCT02497378
- NCT02519452
- NCT02541383
- NCT02626481
- NCT02773030
- NCT02807454
And 222 more, listed on the interactive page.
- Dose
- 1,800 mg daratumumab / 30,000 units hyaluronidase
- Route
- Subcutaneous
- How often
- See tables for specific schedules
Conditions of use
- Administered over approximately 3 to 5 minutes
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Organism
- Homo sapiens
- Sequence
- EVQLLESGGGLVQPGGSLRLSCAVSGFTFNSFAMSWVRQAPGKGLEWVSAISGSGGGTYYADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYFCAKDKILWFGEPVFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- Component
- Light chain
- Type
- Protein
- Organism
- Homo sapiens
- Sequence
- EIVLTQSPATLSLSPGERATLSCRASQSVSSYLAWYQQKPGQAPRLLIYDASNRATGIPARFSGSGSGTDFTLTISSLEPEDFAVYYCQQRSNWPPTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- 57894-502
- 57894-503
- 57894-505
Related records
Trials (417)
- "Monoclonal Antibodies for Treatment of Multiple Myeloma. Emphasis on the CD38 Antibody Daratumumab "
- 2015-12: A Study Exploring the Use of Early and Late Consolidation/Maintenance Therapy
- 225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome
- 68Ga-DOTATATE PET Scan Imaging in Patients With Neuroendocrine Tumors
- A Biomarker-Directed Phase 2 Trial of Tamibarotene (SY-1425) in Participants With Acute Myeloid Leukemia or Myelodysplastic Syndrome
- A Clinical Study Assessing the Subcutaneous Formulation of TQB2934 for Injection in Subjects With Malignant Plasma Cell Tumors
- A Clinical Study to Evaluate SM17 for Atopic Dermatitis
- A Clinical Trail of KJ015 in Patients With HER2-Expressing Solid Tumors
- A Clinical Trial to Assess Safety and Efficacy of Daratumumab in the Treatment of Primary Immune Thrombocytopenia
- A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma
- A Modular, Phase I/II, Multicentre Study to Evaluate AZD4045, in Participants With Relapsed or Refractory Multiple Myeloma
- A Open-Label Phase in Participants With Multiple Myeloma
- A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma
- A Phase 2 Clinical Study of CU-20401
- A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC
- A Phase 3 Trial of DR10624 Versus Placebo in Patients With Severe Hypertriglyceridemia
- A Phase I Study of LXP1788 Injection with Advanced Solid Tumors.
- A Phase Ib/II Clinical Trial of Multiple Doses of STSA-1301 Subcutaneous Injection in Healthy Subjects and Patients With Immune Thrombocytopenia (ITP)
- A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab
- A Phase II Study of TPF With PD-1 Inhibitor Induction Therapy for Locally Advanced Nasopharyngeal Carcinoma
Approved for (3)
- Cancer
- Neoplasm
- Plasma cell myeloma
In development for (44)
- Acute lymphoblastic leukemia Phase 2
- Acute myeloid leukemia Phase 2
- AL amyloidosis Phase 3
- Alzheimer disease Phase 2
- Amyloidosis Phase 3
- Aplastic anemia Phase 1
- Autoimmune thrombocytopenic purpura Phase 2
- B-cell chronic lymphocytic leukemia Phase 2
- Clear cell renal carcinoma Early phase 1
- Colorectal carcinoma Phase 2
- Diffuse large B-cell lymphoma Phase 2
- Follicular lymphoma Phase 2
- Glioblastoma Phase 1
- Glomerulonephritis Phase 2
- Graft versus host disease Phase 1
- Hodgkins lymphoma Phase 1
- Immune system disorder Phase 1
- Leukemia Phase 2
- Lupus nephritis Phase 2
- Lymphoid leukemia Phase 2
Other linked conditions (2)
- Cerebral cavernous malformation
- Plasma cell neoplasm
Targets (1)
- CD38 Lymphocyte differentiation antigen CD38 inhibitor