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# FDA Reconsiders CAR-T Product Warning: Marks
- URL: https://www.fdaweb.com/fda-reconsiders-car-t-product-warning-marks/
- Published: 2024-11-01T12:00:00.000Z
- Updated: 2026-09-14T14:45:56.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5158110

FDA may be backpedaling on safety warnings it required on CAR-T cell therapies related to secondary cancers, less than a year after placing class-wide black box warnings on the products ([see earlier story](https://www.fdaweb.com/malignancy-events-with-car-t-cell-therapies-fda/)). CBER director **Peter Marks** revealed the agency’s shift in an interview with *Fierce Pharma*, noting that certain warnings could be modified or removed.

FDA initially issued the warnings following reports of secondary T-cell malignancies among CAR-T p%atients. [Earlier this year](https://www.fdaweb.com/car-t-cell-benefits-outweigh-risks-marks/), Marks had said that 22 cases out of more than 27,000 treated individuals were documented in FDA’s adverse event system. Although the secondary cancer rate was low compared to some other therapies, Marks explained the agency felt compelled to act based on the reporting surge. He told *Fierce Pharma* that, in hindsight, FDA’s approach may have been “a bit of an overreaction.”

The six CAR-T products affected include Gilead Sciences’ Yescarta and Tecartus, Bristol Myers Squibb’s Breyanzi and Abecma, Johnson & Johnson and Legend Biotech’s Carvykti, and Novartis’ Kymriah. These treatments target blood cancers like large B-cell lymphoma and multiple myeloma. However, FDA warnings and ongoing safety concerns have dampened enthusiasm for CAR-T’s broader applications, including emerging autoimmune treatments.

Marks highlighted FDA's cautious approach when dealing with gene therapies and novel treatments, such as CAR-T, especially as these therapies expand beyond oncology. He suggested that the agency's early stance, while conservative, has spurred a reassessment to balance safety with the therapies’ life-saving potential. Clinical data suggest that CAR-T therapy side effects, including cytokine release syndrome, are less severe in autoimmune patients, possibly justifying revised safety protocols for these conditions.

As CAR-T therapies continue to develop, Marks encouraged biopharma firms to engage with FDA, particularly if safety signals emerge, noting that revising the boxed warnings could support safer use in non-cancer patients.