FDA warning letter
Meta-Analysis Questions FDA Warning on Secondary Cancer Risks With CAR T-Cell Therapies
Researchers analyzed two dozen studies and found similar rates of second primary cancers in patients receiving CAR T-cell and standard therapies.
FDA Requires Boxed Warning of Secondary Cancer Risk for Autologous CAR T-Cell Therapies
The requirement comes after FDA investigated data showing patients developed secondary T-cell malignancies after CD19- and BCMA-directed CAR T-cell therapies.
Cell Therapy Research Consortia Responds to FDA's CAR T-Cell Therapy Warning
Experts in gene and cell therapy, transplantation, and immunotherapy say patients should continue to receive CAR T-cell therapy while the investigation is underway.
FDA Publishes Letter to Novartis Detailing Kymriah Manufacturing Safety Concerns
In the letter, which the agency sent to Novartis in August, FDA inspectors referenced contaminated batches of the cell therapy product and moldy facilities.
FDA Warns of T-Cell Malignancy Risk Following Autologous CAR T-Cell Therapy
Although the agency said the benefits of these treatments still outweigh their risks, it is investigating the potential for serious adverse outcomes and assessing the need for regulatory action.