Blincyto approval (2014)
The FDA approved blinatumomab (Blincyto) in December 2014, the first bispecific T-cell engager. The drug links T cells to leukemia cells with a single engineered antibody, redirecting immune killing without ex vivo cell engineering.
Blincyto gave patients with relapsed acute lymphoblastic leukemia a new option and showed adapter molecules can redirect T cells safely.
Adapter approaches proved powerful but short-lived; Blincyto requires continuous infusion, limiting its practicality.
Demonstrates the appeal and limits of adapter-based T-cell redirection, a cousin of the meditope approach that keeps CAR T cells in the body and updates them on demand.
