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AXICABTAGENE CILOLEUCEL
AXICABTAGENE CILOLEUCEL is a CD19-directed Chimeric Antigen Receptor [EPC] drug. It is currently FDA-approved (first approved 2018).
Axicabtagene ciloleucel is a marketed drug with a key composition patent expiring in 2028. Its primary strength lies in its established market presence and revenue generation. The primary risk is the patent expiry in 2028, which could lead to increased competition.
At a glance
| Generic name | AXICABTAGENE CILOLEUCEL |
|---|---|
| Drug class | CD19-directed Chimeric Antigen Receptor [EPC] |
| Modality | Gene therapy |
| Phase | FDA-approved |
| First approval | 2018 |
Approved indications
Boxed warnings
- WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA 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) ] . Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA. Provide supportive care and/or corticosteroids as needed [see Dosage and Administration (2.2 , 2.3) , 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 YESCARTA [see Warnings and Precautions (5.7) ] . WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC 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 YESCARTA. Do not administer YESCARTA 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 ). Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA. Provide supportive care and/or corticosteroids, as needed ( 2.2 , 2.3 , 5.2 ). T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA ( 5.7 ).
Common side effects
- Cytokine Release Syndrome (CRS)
- Fever
- Hypotension
- Encephalopathy
- Fatigue
- Tachycardia
- Headache
- Nausea
- Febrile Neutropenia
- Diarrhea
- Musculoskeletal Pain
- Infections with Pathogen Unspecified
Serious adverse events
- Cytokine Release Syndrome (CRS)
- Fever
- Encephalopathy
- Hypotension
- Infection with Unspecified Pathogen
- Pneumonia
- Fatal Adverse Reactions
Key clinical trials
- Axi-Cel as a 2nd Line Therapy in Patients With Relapsed/Refractory Aggressive B Lymphoma Ineligible to Autologous Stem Cell Transplantation (PHASE2)
- Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy (PHASE3)
- Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2) (PHASE2)
- A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma (PHASE2)
- Fecal Microbiome Transplant to Remodel Intestinal Microbiota for Patients With Relapsed or Refractory Lymphoma With Exposure to High-Risk Antibiotics Who Are Receiving Chimeric Antigen Receptor T Cells (PHASE2)
- A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy (PHASE3)
- Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma (PHASE3)
- Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- AXICABTAGENE CILOLEUCEL CI brief — competitive landscape report
- AXICABTAGENE CILOLEUCEL updates RSS · CI watch RSS
Frequently asked questions about AXICABTAGENE CILOLEUCEL
What is AXICABTAGENE CILOLEUCEL?
AXICABTAGENE CILOLEUCEL is a CD19-directed Chimeric Antigen Receptor [EPC] drug.
What drug class is AXICABTAGENE CILOLEUCEL in?
AXICABTAGENE CILOLEUCEL belongs to the CD19-directed Chimeric Antigen Receptor [EPC] class. See all CD19-directed Chimeric Antigen Receptor [EPC] drugs at /class/cd19-directed-chimeric-antigen-receptor-epc.
When was AXICABTAGENE CILOLEUCEL approved?
AXICABTAGENE CILOLEUCEL was first approved on 2018.
What development phase is AXICABTAGENE CILOLEUCEL in?
AXICABTAGENE CILOLEUCEL is FDA-approved (marketed).
What are the side effects of AXICABTAGENE CILOLEUCEL?
Common side effects of AXICABTAGENE CILOLEUCEL include Cytokine Release Syndrome (CRS), Fever, Hypotension, Encephalopathy, Fatigue, Tachycardia. Serious adverse events: Cytokine Release Syndrome (CRS), Fever, Encephalopathy, Hypotension.