Approval of First CAR-Ts: Have we Solved all Hurdles for ATMPs?

ABSTRACT: T cells are known as the most potent killer cells of the immune system, designed by nature to prevent unwanted challenges. The first class of therapeutic products harnessing the power of T cells for target-specific treatment of oncological diseases was bispecific antibodies. The first T-cell engaging bispecific antibodies that obtained approval were catumaxomab and blinatumomab1,2. Eight years later, the first chimeric antigen receptor (CAR)-T cells received regulatory approval3. CAR-T cells are the cellular interpretation of T-cell engaging therapies and have shown remarkable clinical results. CAR-T cells belong to the regulatory group of advanced therapy medicinal products (ATMPs). Due to the cell-/gene-based complex nature, ATMPs are far more challenging to develop than other, more defi

SUBMITTER: Seimetz D 

PROVIDER: S-EPMC6343443 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature