MedCity News January 23, 2024
Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply.
Stricter safety warnings are coming for the cancer treatments known as CAR T-therapies. The FDA is instructing makers of the six approved cell therapies in the class to revise their labels to state that these treatments for cancer come with the risk of causing new cancers.
The labels of CAR T-therapies already come with black box warnings that alert physicians and patients of risks that include an excessive immune response and neurotoxicity. Letters sent to the...
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