Thanks Outlander,The other point of interest is that the FDA...

Thanks Outlander,
The other point of interest is that the FDA investigation will focus attention upon viral vectors and their mechanism of action in autologous CAR-T therapies. The lentiviral or retroviral vectors create the potential for insertional mutagenesis or in other words an integration event arising from random, sometimes multiple insertions that turns on an oncogene. The FDA refers to the serious risk of T-cell malignancy.

Has anyone got a CAR-T therapy that doesn't use random, sometimes multiple insertions of the CAR into the T cell genome? I could well imagine that the FDA, with an investigation on its hands into autologous CAR-T immunotherapies, will be keen to see any additional data generated by azer-cel. The news of the investigation is perfect timing with the recent announcement of first patient in for the azer-cel Phase 1b allogeneic CAR-T clinical trial.