News that the US regulator is to investigate links between CAR-T therapies and patients later developing secondary cancers has shocked the field and impacted share prices of smaller companies. But as the US Food and Drug Administration has flagged just 12 cases of T cell malignancies in total so far, and is not talking of any suspension of approval, analysts and companies are preaching calm.
Key Takeaways
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The FDA is to probe cases of T-cell malignancies in CAR-T patients
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It’s not clear if a link can be established, but the cases are nevertheless relatively rare
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Investors
The FDA announced its probe on 28 November into all approved CAR-Ts, which currently total six – four targeting CD19 in lymphoma and two
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