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The FDA grants regenerative medicine advanced therapy (RMAT) designation to tisagenlecleucel for patients with relapsed or refractory follicular lymphoma
By Alia Mohamed
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On April 22, 2020, tisagenlecleucel was granted regenerative medicine advanced therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed or refractory (R/R) follicular lymphoma (FL).1
Tisagenlecleucel is an anti‐CD19 chimeric antigen receptor T cell (CAR T cell) and currently has indications in R/R pediatric and young adult acute lymphoblastic leukemia and R/R adult diffuse large B-cell lymphoma. If approved, R/R FL will be the third indication for tisagenlecleucel. This RMAT designation for tisagenlecleucel in FL was based on preliminary data from the ongoing multicenter phase II ELARA study in adult patients with R/R FL.
U.S. FDA regulatory filing for tisagenlecleucel in R/R FL is anticipated in 2021.
- GlobeNewswire. Novartis Kymriah® receives FDA Regenerative Medicine Advanced Therapy designation in follicular lymphoma. https://www.globenewswire.com/news-release/2020/04/22/2019725/0/en/Novartis-Kymriah-receives-FDA-Regenerative-Medicine-Advanced-Therapy-designation-in-follicular-lymphoma.html. Published Apr 22, 2020. Accessed Apr 22, 2020.
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