RE:RE:CAR-T update November 01, 2024 - The FDA is reconsidering reoving serious safety warnings on CAR-T therapies with plans to change them potentially, Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER), said in an interview with Fierce Pharma.
The industry complained that the FDA treated CAR-T unfairly while there are drugs with larger or similar numbers of secondary cancer reports that are being marketed without this boxed warning item.
Multiple studies have since looked into the risk of secondary cancers after CAR-T therapies. A meta-analysis published recently in the journal Clinical Cancer Research found that the rate of secondary cancer was no greater among patients treated with CAR-T than those on traditional standard of care.
Besides, people with blood cancers already have various risk factors related to the secondary development of cancer in the first place. “Was it perhaps a bit of an overreaction? In retrospect, maybe,” Marks said in the interview.
https://www.fiercepharma.com/pharma/it-was-good-lesson-fda-reconsiders-car-t-boxed-warning-secondary-cancers-peter-marks-says