You'd best add the caveat of them being autlogous cells and not allogeneic, or you will get told off.
But indeed a significant milestone for the FDA as I posted in other threads, in that it is their first approval of genetically engineered CAR T-Cell therapy. - "TECELRA is a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma...." (Adaptimmune)
I think the real relevancy for MSB is the nature of the approval:
"As part of the accelerated approval, a confirmatory trial will be required" (my embolden). It was granted on the back of a 44 patient trial. Another turning of the tide of the FDA approval regime that many have spoken about hopefully with regard to MSB on there threads.
https://www.fiercepharma.com/pharma/adaptimmune-scores-fda-nod-first-engineered-cell-therapy-solid-tumor
Another small positive development in the regulatory backdrop for MSB's FDA ambitions.
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