All CAR-T therapies must now carry boxed warnings on secondary malignancies

All CAR-T therapies must now carry boxed warnings on secondary malignancies

Immunotherapy CAR-T therapy has made a phenomenal difference to the treatment of various blood cancers since it was invented by Carl June and FDA approved since 2017.  CAR-T therapy was initially more well-known for producing a potentially fatal cytokine release syndrome which is now controlled principally by the IL-6 receptor inhibitor antidote tocilizumab.  Despite this therapy being highly dangerous, it was seen as a genuine life saver as long as the doctors have the antidote at hand.  There are now 6 FDA approved CAR-T therapies.  The toxicity of this approach was seemingly acceptable on the benefit-risk calculation.  Nevertheless, murmurings of SAEs including hospitalisations and deaths have hinted at possible other toxic effects of CAR-T.  This came to a head last November when the FDA said it was investigating a “serious risk” of secondary malignancies with the CAR-T approach, which was reiterated by CBER’s Peter Marks barely 2 weeks ago at JPM2024.  Something had to break.  As of the 19th January 2024, the FDA has mandated boxed warnings on all 6 CAR-T therapies (Yescarta, Tecartus, Kymriah, Carvykti, Breyanzi & Abecma) on potential secondary malignancies.  It’s finally had to happen.  And at least the FDA has acted swiftly to provide clarity to clinicians.

READ THE ARTICLE – https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/2024-safety-and-availability-communications

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