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axicabtagene ciloleucel (Yescarta)
Indications:
- refractory large B-cell lymphoma [4] (FDA-approved Oct 2017)
Contraindications:
- primary central nervous system lymphoma
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)
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
* boxed warning
Laboratory:
- daily starting day of infusion
- complete blood count QD
- chemistry 14 panel
- PT, aPTT, INR
- serum C-reactive protein
- serum ferritin
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]
General
chimeric antigen-receptor (CAR) T-cell therapy; tisagenlecleucel; CTL019 (Kymriah)
References
- 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
- 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
PMID: 29226797
http://www.nejm.org/doi/full/10.1056/NEJMoa1707447