Last reviewed · How we verify
Yescarta
At a glance
| Generic name | Yescarta |
|---|---|
| Also known as | axicabtagene ciloleucel KTE-C19 |
| Sponsor | Incyte Corporation |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | FDA-approved |
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,
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
- 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)
- Anakinra in Preventing Severe Chimeric Antigen Receptor T-Cell Related Encephalopathy Syndrome in Patients With Recurrent or Refractory Large B-cell Lymphoma (PHASE2)
- Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
- NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Axicabtagene Ciloleucel or Post-Lisocabtagene Maraleucel in Subjects With Relapsed/Refractory Large B-cell Lymphoma (PHASE1)
- Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma (PHASE1)
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 |
|---|---|
| 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:
- Yescarta CI brief — competitive landscape report
- Yescarta updates RSS · CI watch RSS
- Incyte Corporation portfolio CI