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FDA orders new cancer warnings for CAR-T therapies

January 23, 2024

The CAR-T therapies — Abecma and Breyanzi from Bristol Myers Squibb, Carvykti from Johnson & Johnson and Legend Biotech, Kymriah from Novartis, and Tecartus and Yescarta from Gilead — can drive deep and durable responses in patients with lymphoma, leukemia and multiple myeloma who have progressed following numerous other treatments.

These therapies are made from patients’ own T cells, which are genetically engineered with a “chimeric antigen receptor,” or CAR, that’s aimed at certain protein flags found on malignant cells. Once reinfused, the cells home in and destroy cancers that express that flag. The approved ones target proteins called CD19 or BCMA.

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