A day after the FDA launched an investigation into rare cases of secondary blood cancer in patients who received CAR-T therapies, clinicians are calling it a small risk factor for an otherwise effective drug class.
Regulators are tracking 20 reports of T-cell malignancies since the first CAR-Ts were approved in 2017, including 15 from the FDA’s self-reporting adverse event system FAERS. In the context of the tens of thousands of patients who’ve received CAR-T therapies, that small number represents “an extreme minority,” UChicago faculty physician and Hematopoietic Stem Cell Transplantation Program director Michael Bishop told Endpoints News on Wednesday.
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