Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-231

Following on from my post above, the relevant part is:

“FDA also listed post-treatment T cell malignancy as a potential signal of serious risk/new safety information for this product class, identified by FDA Adverse Event Reporting System (FAERS) in the July - September 2023 quarterly report. FDA concluded, based on an evaluation of data from postmarketing adverse event and clinical trial reports, that mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. FDA has determined that the serious risk of T cell malignancies is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies. Therefore, in January 2024, FDA initiated class safety labeling changes (2024 Safety and Availability Communications). FDA concluded that changes to the Boxed Warning are warranted to highlight the serious risk of T cell malignancies. ”