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Pharmaceuticals / Submissions and Approvals

Novartis Wins Landmark Approval With First Personalized CAR-T Cancer Therapy

Sept. 6, 2017

The FDA opened the doors to a dramatic new method for treating cancer — the genetic modification of a patient’s immune cells to fight the disease — by granting approval to Novartis’ Kymriah.

The agency described the approval of the chimeric antigen receptor T-cell therapy, or CAR-T, as “historic.” Kymriah (tisagenlecleucel) was approved for relapsed patients with B-cell precursor acute lymphoblastic leukemia.

Each dose is cultivated and customized using an individual patient’s white blood cells, which are collected and sent to a manufacturing center. The cells are modified to include a new gene that directs them to attack specific leukemia cells, before being infused back into the patient. Novartis expects the turnaround process to take about three weeks.

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