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These highlights do not include all the information needed to use KYMRIAH safely and effectively. See full prescribing information for KYMRIAH.KYMRIAH® (tisagenlecleucel) suspension for intravenous infusionInitial U.S. Approval: 2017
Medication labelWhy this: Advisory · dailymed-other
KYMRIAH is indicated for 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. KYMRIAH is indicated for treatment of 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. Limitation of Use: KYMRIAH is not indicated for treatment of patients with primary central nervous system lymphoma. KYMRIAH is indicated for treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies (14.3)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
- generic_name
- tisagenlecleucel
- product_names
- tisagenlecleucel
- ndc
- 0078-0846, 0078-0846-19, 0078-0958, 0078-0958-19
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en