Kymriah FDA Approval History
Last updated by Judith Stewart, BPharm on June 1, 2022.
FDA Approved: Yes (First approved August 30, 2017)
Brand name: Kymriah
Generic name: tisagenlecleucel
Dosage form: Suspension for Intravenous Infusion
Previous Name: CTL019
Company: Novartis Pharmaceuticals Corporation
Treatment for: Acute Lymphoblastic Leukemia, B-Cell Lymphoma, Follicular Lymphoma
Kymriah (tisagenlecleucel) is a chimeric antigen receptor T cell (CAR-T) therapy for the treatment of B-cell acute lymphoblastic leukemia (ALL), large B-cell lymphoma, and follicular lymphoma (FL).
- Kymriah is 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).
Development timeline for Kymriah
Further information
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