Hill January 23, 2024
The Food and Drug Administration (FDA) is requiring a boxed warning on all existing CAR-T cancer treatments following a review of reports that the therapies themselves can increase the risk for some secondary cancers.
In letters to the manufacturers of all six currently available CAR-T therapies dated Jan. 19, the FDA said the prescribing information will need to include so-called black box warnings, the most serious type for any medication.
CAR-T is a gene therapy that works by extracting white blood cells known as T-cells from a patient, reengineering them in a lab to attack cancer cells and then infusing them back into the body.
The treatments impacted include Abecma and Breyanzi from Bristol Myers Squibb, Carvykti...
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