Tisagenlecleucel
Highest phase reached
Approved
Drug type
Cell
First approval year
2018
- First approval year
- 2018
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Cell
- Drug name
- Tisagenlecleucel
- kymriah
- Kymriah
- 5 fu lv
- car cd19 redirected t cells
- Car.cd19-redirected t cells
- cart 19
- CART 19
- CART-19
- cart19
- CART19
- ctl 019
- CTL-019
- ctl019
- CTL019
- gene modification of t cells is mediated by stable insertion via transduction with a self inactivating replication deficient lentiviral lv vector containing the ctl019 transgene under the control of the ef 1 alpha promoter the drug product is a mixture of transgene positive and negative t cells that are delivered to the patient on the basis of percent transgene positive t cells
- GENE MODIFICATION OF T CELLS IS MEDIATED BY STABLE INSERTION VIA TRANSDUCTION WITH A SELF-INACTIVATING, REPLICATION-DEFICIENT LENTIVIRAL (LV) VECTOR CONTAINING THE CTL019 TRANSGENE UNDER THE CONTROL OF THE EF-1 ALPHA PROMOTER. THE DRUG PRODUCT IS A MIXTURE OF TRANSGENE POSITIVE AND NEGATIVE T CELLS THAT ARE DELIVERED TO THE PATIENT ON THE BASIS OF PERCENT TRANSGENE POSITIVE T CELLS.
- kymriah
- Kymriah
- KYMRIAH
- Leucovorin (LV) or levoleucovorin
- LV
- tisagenlecleucel
- Tisagenlecleucel
- tisagenlecleucel [INN]
- TISAGENLECLEUCEL [USAN]
- Tisagenlecleucel [WHO-DD]
- tisagenlecleucel inn
And 4 more, listed on the interactive page.
- ATC classification codes
- L01XL04
Sources for recorded values
- CAS registry numbers
- 1823078-37-0
- ChEMBL ID
- CHEMBL3301574
- RxNorm IDs (RxCUI)
- 1986438
- FDA ingredient codes (UNII)
- Q6C9WHR03O
- Status
- Authorised
- Status date
- 23 Aug 2018
- Authorisation date
- 23 Aug 2018
- Approved indications
- Kymriah is indicated for the treatment of: • Paediatric and young adult patients up to and including 25 years of age with B cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post transplant or in second or later relapse. • Adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy. • Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
- Product number
- EMEA/H/C/004090
- Authorisation holder
- Novartis Europharm Limited
- Priority medicines scheme
- Yes
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- Yes
- Conditional approval
- No
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Lymphoma, Large B-Cell, Diffuse
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
European medicines record
- Patents
- 0
- Designations
- 7
- Earliest recorded loss of exclusivity
- 3 May 2032
- First in class
- No
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- Yes
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Boxed warning
- Yes
Mechanisms of action
- Mechanism
- B-lymphocyte antigen CD19 binding agent
- Action type
- BINDING_AGENT
- Target
- B-lymphocyte antigen CD19
- Protein identifier
- P15391
Open Targets mechanisms
- Mechanism
- B-lymphocyte antigen CD19 binding agent
- Action type
- BINDING AGENT
- Target
- B-lymphocyte antigen CD19
- Condition
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000094
- Subject identifier
- D015452
- Condition
- Leukemia, Biphenotypic, Acute
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000094
- Subject identifier
- D015456
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000096
- Subject identifier
- D008224
- Condition
- Hodgkin Disease
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0000183
- Subject identifier
- D006689
- Condition
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000220
- Subject identifier
- D054198
- Condition
- Leukemia, Myeloid, Acute
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000222
- Subject identifier
- D015470
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Leukemia
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000565
- Subject identifier
- D007938
- Condition
- Lymphoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Multiple Myeloma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Leukemia, Lymphoid
- Highest recorded phase
- 1
- Condition identifier
- EFO:0004289
- Subject identifier
- D007945
- Condition
- Lymphoma, Non-Hodgkin
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005952
- Subject identifier
- D008228
- Condition
- Lymphoma, AIDS-Related
- Highest recorded phase
- 1
- Condition identifier
- EFO:1001365
- Subject identifier
- D016483
- Condition
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0000873
- Subject identifier
- D054198
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0018906
- Subject identifier
- D008224
- Condition identifier
- EFO_0000094
- Condition identifier
- EFO_0000095
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000096
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000183
- Condition identifier
- EFO_0000220
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000222
- Condition identifier
- EFO_0000403
- Condition identifier
- EFO_0000565
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001378
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003860
- Condition identifier
- EFO_0004289
- Highest recorded phase
- 1
- Condition identifier
- EFO_0005952
- Highest recorded phase
- 2
- Condition identifier
- EFO_1000359
- Condition identifier
- EFO_1001469
- Highest recorded phase
- 1
- Condition identifier
- EFO_1001938
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0000873
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002571
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0004355
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0004947
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0004948
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0004967
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005059
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005062
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0007243
- Highest recorded phase
- 2
And 11 more, listed on the interactive page.
Warnings
- Warning
- Black Box Warning
- Effect
- infectious disease
Open Targets warnings
- Warning
- Black Box Warning
- Effect
- infectious disease
- Country
- United States
- Event
- acute lymphocytic leukaemia
- Reports
- 16
- Reporting signal score
- 50.9701
- Event
- acute lymphocytic leukaemia recurrent
- Reports
- 95
- Reporting signal score
- 503.757
- Event
- acute myeloid leukaemia
- Reports
- 11
- Reporting signal score
- 17.1686
- Event
- aphasia
- Reports
- 28
- Reporting signal score
- 43.2894
- Event
- b-cell aplasia
- Reports
- 29
- Reporting signal score
- 189.901
- Event
- b-cell type acute leukaemia
- Reports
- 13
- Reporting signal score
- 70.9934
- Event
- b-lymphocyte count abnormal
- Reports
- 21
- Reporting signal score
- 136.045
- Event
- bacteraemia
- Reports
- 12
- Reporting signal score
- 17.714
- Event
- blast cell count increased
- Reports
- 6
- Reporting signal score
- 19.2977
- Event
- blood fibrinogen decreased
- Reports
- 12
- Reporting signal score
- 46.3986
- Event
- bone marrow disorder
- Reports
- 7
- Reporting signal score
- 17.2228
- Event
- bone neoplasm
- Reports
- 7
- Reporting signal score
- 25.5403
- Event
- c-reactive protein increased
- Reports
- 24
- Reporting signal score
- 25.9856
- Event
- cardiorenal syndrome
- Reports
- 6
- Reporting signal score
- 23.4615
- Event
- central nervous system neoplasm
- Reports
- 7
- Reporting signal score
- 36.5498
- Event
- clostridium difficile colitis
- Reports
- 12
- Reporting signal score
- 18.6553
- Event
- clostridium difficile infection
- Reports
- 15
- Reporting signal score
- 20.5537
- Event
- coagulopathy
- Reports
- 25
- Reporting signal score
- 51.2128
- Event
- confusional state
- Reports
- 35
- Reporting signal score
- 14.8204
- Event
- cytokine release syndrome
- Reports
- 532
- Reporting signal score
- 3,010.45
- Event
- cytopenia
- Reports
- 59
- Reporting signal score
- 184.745
- Event
- depressed level of consciousness
- Reports
- 25
- Reporting signal score
- 25.1324
- Event
- diffuse large b-cell lymphoma
- Reports
- 42
- Reporting signal score
- 142.969
- Event
- diffuse large b-cell lymphoma recurrent
- Reports
- 55
- Reporting signal score
- 262.603
- Event
- diffuse large b-cell lymphoma refractory
- Reports
- 8
- Reporting signal score
- 32.3809
And 48 more, listed on the interactive page.
- NCT01551043
- NCT02810223
- NCT03027739
- NCT03123939
- NCT03391739
- NCT03544021
- NCT03628053
- NCT04225676
- NCT06101381
- NCT06367114
- NCT06408194
- NCT01626495
- NCT02476734
- NCT03101709
- NCT04419909
- NCT05776407
- NCT02529813
- NCT02799550
- NCT03321123
- NCT03614858
- NCT01747486
- NCT03853616
- NCT04684563
- NCT05037669
- NCT02030834
And 29 more, listed on the interactive page.
- Dose
- 0.2 to 5.0 x 10^6 CAR-positive viable T cells per kg (pediatric and young adult ALL); 0.1 to 2.5 x 10^8 CAR-positive viable T cells (patients >50 kg); 0.6 to 6.0 x 10^8 CAR-positive viable T cells (adults with DLBCL and FL)
- Route
- Intravenous
- How often
- 2 to 14 days after lymphodepleting chemotherapy for pediatric and young adult ALL; 2 to 11 days after lymphodepleting chemotherapy for adult DLBCL and FL
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
Related records
Trials (103)
- 5-Fluorouracil/Leucovorin (5FU/LV) in Combination With Regorafenib in Patients With Metastatic Colorectal Cancer
- A Clinical Study of Liposomal Irinotecan for Second-Line Therapy in Metastatic Colorectal Cancer
- A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
- A Irinotecan Liposome Trial of in Advanced Neuroendocrine Carcinoma
- A Phase II/III Study of HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate and Bevacizumab Versus FOLFOX in Combination With Bevacizumab for First-line Treatment of Advanced Colorectal Cancer
- A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma
- A Randomized, Two-cohort, Prospective Phase II Clinical Study of the Second-line Treatment of Advanced Biliary System Tumors With Liposomal Irinotecan (II) Combination Regimen
- A Second Infusion (Early Reinfusion) of Tisagenlecleucel in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia(B-ALL)
- A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC)
- A Study of MB-CART19.1 Cellular Therapy for People With Central Nervous System Lymphoma (CNSL)
- A Study of MR001 Combined With Chemotherapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) After First-line Therapy
- A Study of PEP02 in Combination With 5-fluorouracil (5-FU) and Leucovorin (LV) in Advanced Solid Tumors
- A Study of SC-0191 in Subjects With Metastatic Colorectal Cancer
- A Study of YL242 in Subjects With Advanced Solid Tumors
- A Study on the Efficacy and Safety of Irinotecan Liposome (II), 5-FU/LV in Combination With Bevacizumab for the Treatment of Advanced Colorectal Cancer
- A Study to Evaluate a Chemotherapy Treatment Followed by Chemo and Radiotherapy in Patients With Rectal Cancer
- Adebrelimab Combined With Irinotecan Liposomal (II), Oxaliplatin, and 5-FU/LV Conversion Therapy for Locally Advanced Pancreatic Cancer
- Allo CART-19 Protocol
- Allogeneic CART-19 for Elderly Relapsed/Refractory CD19+ ALL
- Autologous CARTmeso/19 Against Pancreatic Cancer
Approved for (2)
- B-cell acute lymphoblastic leukemia
- Diffuse large B-cell lymphoma
In development for (15)
- Acute lymphoblastic leukemia Phase 3
- Acute myeloid leukemia Phase 1
- B-cell chronic lymphocytic leukemia Phase 2
- B-cell non-Hodgkin lymphoma Phase 1
- Childhood leukemia Phase 1
- Follicular lymphoma Phase 3
- Hodgkins lymphoma Early phase 1
- Leukemia Phase 2
- Lymphoblastic lymphoma Phase 3
- Lymphoid leukemia Phase 1
- Lymphoma Phase 1
- Mantle cell lymphoma Phase 1
- Neoplasm of mature B-cells Phase 3
- Non-Hodgkin lymphoma Phase 3
- Plasma cell myeloma Phase 2
Other linked conditions (3)
- Acute myeloid leukemia by FAB classification
- Malignant pancreatic neoplasm
- Pancreatic neoplasm
Targets (1)
- CD19 B-lymphocyte antigen CD19 binding agent