In the recent months regulatory authorities have issued warnings related to risk of secondary malignancies following CART therapies
Follow-up information released by FDA via NEJM perspectives article
Secondary Cancers after Chimeric Antigen Receptor T-Cell Therapy
Authored by Nicole Verdun (Super Office Director, CBER, FDA) & Peter Marks
*5/6 approved CAR T had patients develop a secondary malignancy
*22 cases out of >27,000 doses
*Secondary malignancies occurred between 1-19 months post infusion
*In 3 cases, the CAR transgene was found in the malignant clone suggesting the CAR was associated with the cancer
FDA Investigating Serious Risk of T-cell Malignancy
A Commentary from Industry with their assessment of the risk
https://www.nature.com/articles/s41591-023-02767-w
Bruce Levine, Ph.D. 🇺🇦 on Twitter: "🚨NEW Commentary on #FDA 11/28/23 announcement "Unanswered questions following reports of secondary malignancies after CAR-T cell therapy" @NatureMedicine - A consensus commentary from @ISCTGlobal @ASTCT @TheEBMT @CIBMTR @parkerici @mpasca @John_E_Connolly David Porter... pic.twitter.com/ce7oqvWAZP / Twitter"
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Vibha Jawa
Executive Director
Clinical Pharmacology and Pharmacometrics Disposition and Bioanalysis
Bristol-Myers Squibb
Princeton,NJ
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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