There are some interesting points in the Tecartus sBLA documents. #CARTcells
📌 formulation volume change
📌 BCA did not last past 12 months
📌 IL-6 was the only biomarker identified for both CRS Grade 3 and above AND NT Grade 3 and above
📌 Numerous trial variables
📌 formulation volume change
📌 BCA did not last past 12 months
📌 IL-6 was the only biomarker identified for both CRS Grade 3 and above AND NT Grade 3 and above
📌 Numerous trial variables
📌 3 of the 29 sites were inspected — including the 2 sites with the most important protocol deviations: Moffitt; Emory; and UChicago
📌 Insufficient MRD assay data for review by CDRH
📌 PROs were not assessed as part of the sBLA
📌 Insufficient MRD assay data for review by CDRH
📌 PROs were not assessed as part of the sBLA
📌 retreatment data from ZUMA-3 were heavily redacted
📌 FDA identified 3 major trial design issues with ZUMA-3
📌 extrapolation to pediatric population was not possible
📌 FDA identified 3 major trial design issues with ZUMA-3
📌 extrapolation to pediatric population was not possible
📌 FDA and Kite disagreed on quite a few fatalities
📌 FDA noted that the data supporting the use of alternative IL-6 inhibitors (e.g., anakinra) are limited
📌 FDA noted that the data supporting the use of alternative IL-6 inhibitors (e.g., anakinra) are limited
📌 HLH/MAS emerged as a new safety signal in ALL subjects (relative to subjects with MCL)
📌 HLH/MAS treatment is dictated by institutional standards
📌 HLH/MAS treatment is dictated by institutional standards
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