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

• 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.

Product Information

• 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.

Supporting Documents

• 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

Related Information

• FDA approval brings first gene therapy to the United States
• Approved Risk Evaluation and Mitigation Strategies (REMS) - KYMRIAH