U.S. License Holder:
Novartis Pharmaceuticals Corp.
Date of License:
KYMRIAH (tisagenlecleucel) 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. 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.