Kymriah (tisagenlecleucel) · Novartis
KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular...
Details
- Status
- Prescription
- First Approved
- 2017-08-29
- Patent Cliff
- 2029
- Revenue
- $143M (Q4-2021)
- Routes
- Intravenous
- Dosage Forms
- Injection
Kymriah Approval History
What Kymriah Treats
5 indicationsKymriah is approved for 5 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- B-Cell Precursor Acute Lymphoblastic Leukemia
- Large B-Cell Lymphoma
- Diffuse Large B-Cell Lymphoma
- High Grade B-Cell Lymphoma
- Follicular Lymphoma
Kymriah Boxed Warning
CYTOKINE RELEASE SYNDROME, NEUROLOGICAL TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving KYMRIAH. Do not administer KYMRIAH to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids [see Dosage and Administration (2.2, 2.3), Warnings and Precautions (5.1)]. Neurological toxicities, including ...
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGICAL TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving KYMRIAH. Do not administer KYMRIAH to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids [see Dosage and Administration (2.2, 2.3), Warnings and Precautions (5.1)]. Neurological toxicities, including severe or life-threatening reactions, occurred following treatment with KYMRIAH, including concurrently with CRS. Monitor for neurological events after treatment with KYMRIAH. Provide supportive care and/or corticosteroids as needed [see Warnings and Precautions (5.2)]. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19- directed genetically modified autologous T cell immunotherapies, including KYMRIAH [see Warnings and Precautions (5.8)]. WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGICAL TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES See full prescribing information for complete boxed warning. Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving KYMRIAH. Do not administer KYMRIAH to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. ( 2.2 , 2.3 , 5.1 ) Neurological toxicities, including severe or life-threatening reactions, occurred following treatment with KYMRIAH, including concurrently with CRS. Monitor for neurological events after treatment with KYMRIAH. Provide supportive care and/or corticosteroids as needed. ( 5.2 ) T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19- directed genetically modified autologous T cell immunotherapies, including KYMRIAH. ( 5.8 )
Kymriah Target & Pathway
ProTarget
A protein expressed on B-cells throughout their development. CD19 is a key target for CAR-T cell therapies in B-cell leukemias and lymphomas, where engineered T-cells are directed to kill CD19-expressing cancer cells.
Kymriah Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in Kymriah's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications Kymriah treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to Kymriah
3 of 19FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Novartis's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05888493 LEDA | CCTL019E2301 2023-503452-27-00 | Ph 3 | active not recruiting | A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma |
| NCT06408194 | IRB-74214 NCI-2024-04331 | Ph 1 | recruiting | Autologous CD22 CAR T Cells Following Commercial CD19 CAR T Cells in B Cell Malignancies |
| NCT05460533 | 22-220 | Ph 2 | active not recruiting | A Second Infusion (Early Reinfusion) of Tisagenlecleucel in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia(B-ALL) |
| NCT05633615 | S2114 NCI-2022-07930, S2114 | Ph 2 | recruiting | Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma |
| NCT03642626 results posted | 2017LS118 MT2017-45, NCI-2020-04527 | Ph 2 | active not recruiting | MT2017-45: CAR-T Cell Therapy for Heme Malignancies |
| NCT04855253 | 2020LS100 MT2020-27 | Ph 1, Ph 2 | suspended | Ph I/II Study of E7777 Prior to CAR-T for R/R LBCL |
| NCT04134117 | 19-319 | Ph 1 | completed | Tisagenlecleucel In Primary CNS Lymphoma |
| NCT05075603 | NIT-112 | Ph 1 | completed | Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy |
| NCT03568461 ELARA results posted | CCTL019E2202 2017-004385-94, 2023-508127-13-00 | Ph 2 | completed | Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma |
| NCT03610724 BIANCA results posted | CCTL019C2202 2017-005019-15 | Ph 2 | completed | Phase II Open Label Trial to Determine Safety & Efficacy of Tisagenlecleucel in Pediatric Non-Hodgkin Lymphoma Patients |
| NCT02445248 JULIET results posted | CCTL019C2201 2014-003060-20 | Ph 2 | completed | Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients |
| NCT04156659 | CCTL019B2210 | Ph 2 | withdrawn | Study of Tisagenlecleucel in Chinese Pediatric and Young Adult Subjects With Relapsed or Refractory B-cell ALL |
| NCT03876028 | CCTL019L12101C | Ph 1 | terminated | Study of Tisagenlecleucel in Combination With Ibrutinib in r/r Diffuse Large B-cell Lymphoma Patients |
| NCT04225676 results posted | CCTL019BUS03 | Ph 2 | terminated | Study of Efficacy and Safety of Reinfusion of Tisagenlecleucel in Pediatric and Young Adult Patients With Acute Lymphoblastic Leukemia (ALL) |
| NCT03630159 PORTIA | CCTL019J2101 2018-000973-57 | Ph 1 | completed | Study of Tisagenlecleucel in Combination With Pembrolizumab in r/r Diffuse Large B-cell Lymphoma Patients |
| NCT02529813 | 2013-1018 NCI-2015-01492, 20152145 | Ph 1 | completed | CD19-Specific T-cells in Treating Patients With Advanced Lymphoid Malignancies |
| NCT04456023 | CCTL019C2203 | Ph 2 | withdrawn | Study of Tisagenlecleucel in Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-cell Non-Hodgkin Lymphoma (DLBCL) |
| NCT03628053 OBERON | CCTL019I2301 | Ph 3 | withdrawn | Tisagenlecleucel vs Blinatumomab or Inotuzumab for Patients With Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
Kymriah FDA Label Details
Indications & Usage
KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Limitations of Use : KYMRIAH is not indicated for treatment of patients with primary centr...
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGICAL TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving KYMRIAH. Do not administer KYMRIAH to patients with active infection or inflammatory di...
Pro Intelligence Preview
Deep insights for Kymriah
Revenue Insights
- • Q4-2021: $143M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 19 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.