FDA nod for Tecartus, first CAR-T for relapsed or refractory B-cell ALL in adults

The US Food and Drug Administration has granted approval for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), scoring a first for Kite, a subsidiary of Gilead Sciences (Nasdaq: GILD).

Following FDA Breakthrough Therapy designation and a priority review, Tecartus is the first and only chimeric antigen receptor (CAR) T-cell therapy approved for adults (18 years and older) with ALL. There is a high unmet need, as half of this patient population will relapse, and median overall survival (OS) is only approximately eight months with current standard-of-care treatments. Patients can access Tecartus through 109 authorized treatment centers across the USA, Kite noted.

However, the Kite drug will still have competition, notably in the form of Novartis’s (NOVN: VX) Kymriah (tisagenlecleucel), which was approved for relapsed/refractory ALL in 2017, but its label only covers use in children and young adults aged up to 25, who account for the bulk of cases of the blood cancer.