Thus far in 2023:

One cell therapy BLA approved by the FDA (1st expanded hematopoietic stem cell product, 1st manufactured umbilical cord blood services product).

Four advanced therapies BLA submissions:

• First Iovance (1st TIL cell therapy),
• Next, Adaptimmune (1st engineered TCR cell therapy),
• Then, 1st BLA submission for a CRISPR-based therapy,
• Finally, a fourth BLA submission less than a month later by Bluebird Bio for their gene modified HSC cell therapy. If approved that would make 3 commercial advanced therapies in one company, which may be a record!

A record-setting year to-date for cell and gene therapies!