Novartis Kymriah receives FDA Regenerative Medicine Advanced Therapy designation in follicular lymphoma
- If approved, relapsed or refractory (r/r) follicular lymphoma would become the third B-cell malignancy indication for Kymriah, joining approvals in children and young adults with r/r ALL, and adults with r/r DLBCL
- The Regenerative Medicine Advanced Therapy (RMAT) designation reflects the unmet need for patients with r/r follicular lymphoma
- US regulatory filing for Kymriah in r/r follicular lymphoma anticipated in 2021
- The Non-Hodgkin?s Lymphoma Classification Project.?Blood.?1997;89:3909?3918
- Anderson J., et al. Epidemiology of the non-Hodgkin?s lymphomas: distributions of the major subtypes differ by geographic locations. Non-Hodgkin?s Lymphoma Classification Project.?Ann Oncol.?1998;9(7):7;17?720.
- Wudhikarn, K. et al. Comparative effectiveness research in follicular lymphoma: current and future perspectives and challenges.?J Comp Eff Res.?2014.
- Sutamtewagul, G. & Link, B.K. Novel treatment approaches and future perspectives in follicular lymphoma.?Ther Adv Hematol?2019;10:1?20.
- Data on File, Novartis, 2019.
- Schuster, S., et al. Chimeric antigen receptor T cells in refractory B-cell lymphomas.?NEJM.?2017;377(26):2545?2554.
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Novartis Media Relations E-mail:?media.relations@novartis.comAnja von Treskow Novartis External Communications +41 79 392 8697 anja.von_treskow@novartis.com Eric Althoff Novartis US External Communications +1 646 438 4335 eric.althoff@novartis.com | Fiona Phillips Novartis Oncology Communications +1 862 778-7705 (direct) +1 862-217-9396 (mobile) fiona.phillips@novartis.com |
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