Proper Name: tisagenlecleucel
Manufacturer: Novartis Pharmaceuticals Corporation
- Patients up to 25 years of age with B-cell precursor acute lymphoblasticleukemia (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.
- Package Insert-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.
- May 1, 2018 Approval Letter - KYMRIAH
- April 13, 2018 Summary Basis for Regulatory Action - KYMRIAH
- August 30, 2017 Approval Letter - KYMRIAH
- August 30, 2017 Summary Basis for Regulatory Action - KYMRIAH
- Approval History, Letters, Reviews and Related Documents - KYMRIAH