Thread by @sesiegler

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

📌 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

📌 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 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

📌 HLH/MAS emerged as a new safety signal in ALL subjects (relative to subjects with MCL)

📌 HLH/MAS treatment is dictated by institutional standards