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FDA OKs Tisagenlecleucel in ALL as First Approved CAR T-Cell Therapy

Jason M. Broderick @jasoncology
Published: Wednesday, Aug 30, 2017

The FDA issued a historic approval of the first chimeric antigen receptor (CAR) T-cell Therapy, authorizing the use of tisagenlecleucel (Kymriah) for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.

Investigators concluded that tisagenlecleucel was associated with clinically meaningful remissions. The estimated relapse-free rate among responders at month 6 was 75.4% (95% CI, 57.2-86.7). The median duration of response was not reached at a median follow-up of 4.8 months.


Eleven patients who had CR or CRi relapsed after tisagenlecleucel prior to data cutoff and before any new cancer therapy. Two other patients relapsed after receiving both tisagenlecleucel and new cancer therapy. Of the 52 patients who had CR or CRi, 29 were still in remission at the last assessment before the data cutoff.

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