axicabtagene ciloleucel (Yescarta)
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Indications
- refractory large B-cell lymphoma[4] (FDA-approved Oct 2017)
Contraindications
Monitor
- neurologic assessment every 8 hours
Adverse effects
- cytokine release syndrome (cytokine storm)* most common
- CAR T-cell-related encephalopathy (CRES) 2nd most common
- may result in fatal cerebral edema[4]
- infections, anemia
- adverse effects usually appear in the first week or two
Laboratory
- daily starting day of infusion
Procedure
- a tumor-binding element is introduced into a patient's T-cells using viral vectors
- these T-cells are cultured to produce large numbers of such cells, then reinfused into the patient
- modified T-cells attack leukemia cells with CD19 antigen (B-cells)
Mechanism of action
- adoptive cell transfer therapy
- person's T-cells are engineered to target CD19
Notes
- list price of Yescarta in the U.S. will be $373,000 for for one-time treatment[1]
More general terms
References
- ↑ 1.0 1.1 Fiore K FDA Okays Another CAR T-Cell Therapy - First to treat certain types of non-Hodgkin lymphoma MedPage Today. October 18, 2017 https://www.medpagetoday.com/HematologyOncology/Hematology/68643
- ↑ FDA News Release. Oct 18, 2017 FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma. Yescarta is the second gene therapy product approved in the U.S. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm581216.htm
FDA approves axicabtagene ciloleucel for large B-cell lymphoma. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm581296.htm - ↑ Wikipedia: Axicabtagene ciloleucel https://en.wikipedia.org/wiki/Axicabtagene_ciloleucel
- ↑ 4.0 4.1 4.2 Neelapu SS, Locke FL, Bartlett NL et al Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma. N Engl J Med. Dec 10, 2017 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/29226797 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1707447