FDA Designates CT103A, CAR T-cell Therapy, an Orphan Drug

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FDA Designates CT103A, CAR T-cell Therapy, an Orphan Drug
February 22, 2022February 22, 2022
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The U.S. Food and Drug Administration (FDA) has granted orphan drug status to CT103A, an experimental CAR T-cell therapy that IASO Biotherapeutics and Innovent Biologics are developing to treat relapsed or refractory multiple myeloma. Orphan drug designation is given to therapies with a potential to substantially improve care for rare diseases, defined as conditions affecting 200,000 or fewer people in the U.S. It confers certain incentives to the therapy’s developers; in particular, orphan drugs are…

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