FDA approves first CAR T therapy (2017)
In August 2017, the FDA approved Kymriah (tisagenlecleucel) for children and young adults with relapsed B-cell acute lymphoblastic leukemia. It was the first gene therapy engineered from a patient's own T cells to attack cancer.
Kymriah produced response rates above 80% in pivotal trials and opened the door to a wave of CAR T approvals.
CAR T became a standard option for certain blood cancers, but solid tumors proved far harder to crack because of antigen heterogeneity and the tumor microenvironment.
Shows the baseline meCAR T builds on, and the solid tumor limits the platform is designed to address.
