FDA director says CAR-T ‘incredibly beneficial’ despite secondary malignancy risk

Benefits of chimeric antigen receptor T-cell therapy far outweigh the risks involved, including secondary T-cell malignancies, according to Peter Marks, MD, PhD, director of the FDA’s Center for Biologic Evaluation and Research.
The FDA issued a safety advisory for patients receiving CAR-T regarding T-cell malignancies at the end of November, but Marks said only 22 cases out of more than 27,000 individuals treated had been reported by the end of 2023.
“Make no mistake, the overall risk-benefit profile [for CAR-T] is still incredibly beneficial,” Marks said during the Alliance

Leave a Comment

Your email address will not be published. Required fields are marked *

Shopping Cart
This website uses cookies and asks your personal data to enhance your browsing experience.