A US Food and Drug Administration alert about reports of T-cell malignancies with CAR-T therapies could heighten safety scrutiny of lentiviral and retroviral-based gene therapies in general and temper enthusiasm for use of CAR-T products outside of oncology/hematology indications.
CAR-T Malignancy Reports Could Temper Excitement For Use Beyond Oncology
US FDA has received a total of 19 reports of T-cell malignancy involving BCMA- or CD19-directed autologous CAR-T cell immunotherapies and is evaluating the need for regulatory action. Focus on lentiviral and retroviral vectors could extend to safety of other types of gene therapies.
More from Drug Safety
• By
Filing in the Whole Women’s Health mifepristone case defends the FDA’s 2023 decision on the abortion pill safety program, but experts warn it does not necessarily signal the Trump Administration position in other mifepristone cases attempting to restrict medication abortion access.
• By
The Pink Sheet drug review profile investigates the long and rigorous process behind the FDA’s recent relaxation of the cardiovascular safety warning for testosterone products.
• By
The Pink Sheet Drug Review Profile breaks down the FDA's long reckoning with testosterone cardiovascular safety concerns
• By
A new EU public-private initiative is developing tools to help clarify when mini- and micropig models can be used as viable alternatives to non-human primates in non-clinical drug safety testing.
More from Pink Sheet
• By
Pink Sheet reporter and editors discuss how staff may not be the only thing the FDA could lose with the latest layoffs announced by the Health and Human Services Department.
• By
The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
• By
Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.