FDA Warns of Increased Cancer Risk from CAR-T Therapies

TL;DR Summary
The FDA has issued a warning that CAR-T therapies, which involve genetically engineering T cells to target and kill cancer cells, may themselves cause secondary blood cancers. The agency has required companies to add a boxed warning to these specialized cancer treatments, despite noting that the benefits still outweigh the risks. While the therapy has been used by at least 27,000 patients since 2017, reports of about 25 cases of secondary cancers have raised concerns, although further investigation is needed to establish a definite link.
- F.D.A. Issues Warning of Cancer Risk Linked to CAR-T Therapies The New York Times
- FDA says cancer treatment CAR-T therapy may increase risk of cancer NBC News
- FDA warns of risks from cancer treatments The Hill
- Pharmalittle: We're reading about FDA warnings on CAR-T drugs, a Sanofi deal, and more STAT
- FDA Calls for Boxed Warnings on CAR-T Therapies Regarding Secondary Cancer Risks BioSpace
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