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