Isatuximab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2020
- First approval year
- 2020
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Isatuximab
- sarclisa
- Sarclisa
- isatuximab
- Isatuximab
- Isatuximab (for expansion)
- Isatuximab (for run-in portion)
- isatuximab [INN]
- ISATUXIMAB [JAN]
- ISATUXIMAB [MI]
- ISATUXIMAB [USAN]
- Isatuximab [WHO-DD]
- Isatuximab Injection
- isatuximab inn
- isatuximab irfc
- Isatuximab irfc
- Isatuximab irfc [WHO-DD]
- isatuximab irfc who dd
- Isatuximab IV
- isatuximab jan
- isatuximab mi
- isatuximab usan
- isatuximab who dd
- Isatuximab-irfc
- sar 650984
- SAR-650984
- sar650984
- SAR650984
And 2 more, listed on the interactive page.
- CAS registry numbers
- 1461640-62-9
- ChEMBL ID
- CHEMBL3545131
- FDA ingredient codes (UNII)
- R30772KCU0
- L01FC02
- L01XC38
Sources for recorded values
- 2282018
- 2282019
- Applicant
- SANOFI AVENTIS US
- Approval date
- 2 Mar 2020
- Application number
- BLA761113
- Status
- Authorised
- Status date
- 30 May 2020
- Authorisation date
- 30 May 2020
- Approved indications
- Sarclisa is indicated: In combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. In combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. In combination with bortezomib, lenalidomide, and dexamethasone, 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 induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
- Product number
- EMEA/H/C/004977
- Authorisation holder
- Sanofi Winthrop Industrie
- 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
- No
- Exceptional circumstances
- No
Therapeutic areas
- Multiple Myeloma
European medicines record
- Patents
- 0
- Designations
- 1
- Earliest recorded loss of exclusivity
- 20 Sept 2031
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- isatuximab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Binding
- Action type
- Binding
- Target
- CD38
- Gene symbol
- CD38
- Protein identifier
- P28907
- 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
- Paraproteinemias
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000203
- Subject identifier
- D010265
- 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
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Immune System Diseases
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000540
- Subject identifier
- D007154
- 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
- Multiple Myeloma
- Highest recorded phase
- 4
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Hematologic Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001642
- Subject identifier
- D019337
- Condition
- Smoldering Multiple Myeloma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003073
- Subject identifier
- D000075122
- Condition
- Leukemia, T-Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005592
- Subject identifier
- D015458
- Condition
- Anemia, Hemolytic, Autoimmune
- Highest recorded phase
- 1
- Condition identifier
- EFO:1001264
- Subject identifier
- D000744
- Condition
- Red-Cell Aplasia, Pure
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0001705
- Subject identifier
- D012010
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0005575
- Subject identifier
- D015179
- Condition
- Amyloidosis, Familial
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0019438
- Subject identifier
- D028226
- Condition
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0044917
- Subject identifier
- D054218
- Condition identifier
- EFO_0000203
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000209
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000540
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0001378
- Condition identifier
- EFO_0003073
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004599
- Highest recorded phase
- 2
- Condition identifier
- EFO_0010134
- Highest recorded phase
- 1
- Condition identifier
- EFO_1001264
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001830
- Highest recorded phase
- 2
- Condition identifier
- HP_0012410
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0000430
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0001705
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0003539
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004963
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004967
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005062
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005070
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005140
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005233
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005235
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005240
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005575
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0007256
- Highest recorded phase
- 1
And 13 more, listed on the interactive page.
- Event
- acute kidney injury
- Reports
- 25
- Reporting signal score
- 10.8082
- Event
- arthralgia
- Reports
- 1
- Reporting signal score
- 12.5371
- Event
- asthenia
- Reports
- 1
- Reporting signal score
- 12.1214
- Event
- atypical haemolytic uraemic syndrome
- Reports
- 3
- Reporting signal score
- 9.76386
- Event
- cholangiocarcinoma
- Reports
- 3
- Reporting signal score
- 8.81575
- Event
- covid-19
- Reports
- 19
- Reporting signal score
- 21.3533
- Event
- covid-19 pneumonia
- Reports
- 10
- Reporting signal score
- 26.0815
- Event
- cytomegalovirus colitis
- Reports
- 4
- Reporting signal score
- 9.32198
- Event
- dizziness
- Reports
- 1
- Reporting signal score
- 17.2993
- Event
- fatigue
- Reports
- 9
- Reporting signal score
- 10.7
- Event
- febrile bone marrow aplasia
- Reports
- 12
- Reporting signal score
- 31.1148
- Event
- febrile infection
- Reports
- 7
- Reporting signal score
- 24.711
- Event
- febrile neutropenia
- Reports
- 36
- Reporting signal score
- 46.3557
- Event
- gastrointestinal inflammation
- Reports
- 5
- Reporting signal score
- 9.79567
- Event
- giant cell myocarditis
- Reports
- 2
- Reporting signal score
- 12.9671
- Event
- headache
- Reports
- 4
- Reporting signal score
- 14.0315
- Event
- hypogammaglobulinaemia
- Reports
- 5
- Reporting signal score
- 8.59962
- Event
- infusion related reaction
- Reports
- 74
- Reporting signal score
- 154.796
- Event
- ivth nerve paralysis
- Reports
- 3
- Reporting signal score
- 12.7252
- Event
- lymphopenia
- Reports
- 11
- Reporting signal score
- 15.2739
- Event
- malaise
- Reports
- 2
- Reporting signal score
- 11.0276
- Event
- neutropenia
- Reports
- 57
- Reporting signal score
- 58.5187
- Event
- parainfluenzae virus infection
- Reports
- 5
- Reporting signal score
- 15.5114
- Event
- pericarditis infective
- Reports
- 2
- Reporting signal score
- 8.92568
- Event
- plasma cell myeloma
- Reports
- 20
- Reporting signal score
- 29.9944
And 9 more, listed on the interactive page.
- NCT01084252
- NCT01749969
- NCT02283775
- NCT02332850
- NCT02513186
- NCT02514668
- NCT02812706
- NCT02990338
- NCT03104842
- NCT03194867
- NCT03275285
- NCT03319667
- NCT03530683
- NCT03617731
- NCT03733717
- NCT03989414
- NCT04045795
- NCT04083898
- NCT04126200
- NCT04240054
- NCT04270409
- NCT04287855
- NCT04430894
- NCT04483739
- NCT04558931
And 41 more, listed on the interactive page.
- Dose
- 10 mg/kg
- Route
- Intravenous
- How often
- See dosing schedules in clinical studies and tables
- Administer by healthcare professional
- Administer infusion over the time specified in infusion rate table
- Premedicate with dexamethasone, acetaminophen, H2 antagonist, and diphenhydramine
- Prepare infusion using aseptic technique, administer within 48 hours of preparation
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Light chain
- Type
- Protein
- Sequence
- DIVMTQSHLSMSTSLGDPVSITCKASQDVSTVVAWYQQKPGQSPRRLIYSASYRYIGVPDRFTGSGAGTDFTFTISSVQAEDLAVYYCQQHYSPPYTFGGGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Heavy chain
- Type
- Protein
- Sequence
- QVQLVQSGAEVAKPGTSVKLSCKASGYTFTDYWMQWVKQRPGQGLEWIGTIYPGDGDTGYAQKFQGKATLTADKSSKTVYMHLSSLASEDSAVYYCARGDYYGSNSLDYWGQGTSVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- 0024-0654
- 0024-0656
- 0024-0674
Related records
Trials (151)
- A 3-cohort Randomized Study Evaluating the Role of New Immunotherapeutic Agents and of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Frontline Therapy of Adults With Acute Lymphoblastic Leukemia
- A Clinical Trial of KVA12123 [TBS-2025] Treatment Alone and in Combination With Pembrolizumab In Advanced Solid Tumors (VISTA-101)
- A Clinical Trial to Learn About the Study Medicine Called Maplirpacept (PF-07901801), Alone and When Used in Combination With Other Medicines to Treat Participants With Advanced Hematological Malignancies, Including Lymphoma, Leukemia and Multiple Myeloma
- A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors
- A Phase 1b Study of WU-NK-101 in Combination With Cetuximab
- A Phase 2 Study of Isatuximab in Combination With Bortezomib, Cyclophosphamide and Dexamethasone Followed by Isatuximab and Lenalidomide Maintenance in Newly Diagnosed Patients With Multiple Myeloma and Severe Renal Impairment
- A Phase 2 Study of Isatuximab in Combination With Pomalidomide and Dexamethasone in MM Patients Who Received One Prior Line of Therapy Containing Lenalidomide and a Proteasome Inhibitor
- A Phase I Study of CFT8919 in Patients With Advanced NSCLC
- A Phase I Study of FCN-411 in Advanced Non-small Cell Lung Cancer Chinese Patients With EGFR Positive Mutation
- A Phase I Study of SIM0609 in Adult Participants With Locally Advanced/Metastatic Solid Tumors
- A Phase I/II Study of ABSK141 in Patients With Advanced Solid Tumors ( ABSK141-101 )
- A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849
- A Pilot Trial Using Isatuximab to Overcome Platelet Transfusion Refractoriness in Human Leukocyte Antigen Allo-Immunized Patients (SuppCare 001)
- A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
- A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)
- A Study of a New Investigational Medicinal Product to Treat Patients with Advanced or Metastatic Solid Tumors
- A Study of CM24 in Combination with Nivolumab in Adults with Advanced Solid Tumors
- A Study of HMPL-295S1 in Patients With Advanced Malignant Solid Tumors
- A Study of Intraperitoneally Administered AVB-001 in Patients With Serous Adenocarcinoma of the Ovary
- A Study of Isatuximab-based Therapy in Participants With Lymphoma
Approved for (2)
- Neoplasm
- Plasma cell myeloma
In development for (17)
- Acute lymphoblastic leukemia Phase 2
- Acute myeloid leukemia Phase 2
- AL amyloidosis Phase 2
- Autoimmune hemolytic anemia Phase 1
- Colorectal cancer Phase 1
- Diffuse large B-cell lymphoma Phase 1
- Immune system disorder Phase 1
- Lymphoid neoplasm Phase 1
- Lymphoma Phase 2
- Monoclonal gammopathy Phase 2
- Precursor T-cell acute lymphoblastic leukemia Phase 2
- Pure red-cell aplasia Phase 2
- Smoldering plasma cell myeloma Phase 2
- T-cell acute lymphoblastic leukemia Phase 2
- T-cell leukemia Phase 2
- T-lymphoblastic lymphoma Phase 2
- Timothy syndrome Phase 2
Targets (1)
- CD38 Lymphocyte differentiation antigen CD38 inhibitor