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CAR-T Safety Probe Causes Alarm, But Is Unlikely To Upend Therapies

 
• By Andrew McConaghie

Hopes are that the impact of the US FDA’s investigation into a small number of T-cell malignancies associated with CAR-T therapies will be small since the benefit/risk profile still looks sound.

FDA building.
• Source: Shutterstock

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

  • The FDA is to probe cases of T-cell malignancies in CAR-T patients

  • It’s not clear if a link...

The FDA announced its probe on 28 November into all approved CAR-Ts, which currently total six – four targeting CD19 in lymphoma and two targeting BCMA in multiple myeloma (see...

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