CAR T-Cell Therapy HCP Guide – CAR T-Cell Therapy at the FDA

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Axicabtagene ciloleucel (KTE-C19) from Kite Pharma was the first CAR T-cell therapy submitted to the FDA for approval in March 2017. For the current submission, axicabtagene ciloleucel has been studied in relapsed or chemotherapy-refractory B-cell non-Hodgkin lymphoma (B-NHL) patients who are ineligible for autologous stem cell transplant (ASCT). If approved, Kite plans to commercially launch axicabtagene ciloleucel in 2017.

The manufacturing of CAR T-cell therapy is both astounding and complicated at the same time. A bioengineering feat, the CAR T-cells are constructed from the patient’s own T lymphocytes to boost their cancer-killing ability, and then re-infused back into the patient with directions to target and kill the cancer cells.

CAR T-cells are also under study for B-cell acute lymphoblastic leukemia (B-ALL), and chronic lymphocytic leukemia (CLL), as well as in numerous solid tumor trials.

Learn More:

KTE-C19 Zuma 1 Clinical Trials
KTE-C19 Zuma 2 Clinical Trials
KTE-C19 Zuma 3 & 4 Clinical Trials
KTE-C19 Zuma 6 Clinical Trials

Sources for CAR-T Cell Therapy HCP Guide by Drugs.com