KYMRIAH (tisagenlecleucel)

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 adult patients with relapsed or refractory follicular lymphoma after two or more lines of therapy

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 26, 2022 Clinical Memo - KYMRIAH
• April 01, 2022 Statistical Review - KYMRIAH
• May 27, 2022 Approval Letter - KYMRIAH
• June 11, 2021 Approval Letter - KYMRIAH
• 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
• Approved Risk Evaluation and Mitigation Strategies (REMS) - 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