KYMRIAH

STN: 125646
Proper Name: tisagenlecleucel
Tradename: KYMRIAH
Manufacturer: Novartis Pharmaceuticals Corporation
Indication:

KYMRIAH is a CD19-directed genetically modified autologous T-cell immunotherapy indicated for the 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.
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.

Limitations of Use: KYMRIAH is not indicated for treatment of patients with primary central nervous system lymphoma.
Adult patients with relapsed or refractory 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Product Information

Package Insert and Medication Guide - KYMRIAH
Demographic Subgroup Information - tisagenlecleucel [KYMRIAH]
Refer to Section 1.1 of the clinical reviewer memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.