FDA

FDA adds Boxed Warning for enterocolitis risk with Carvykti

October 15, 2025

FDA approved updated labeling for Carvykti (ciltacabtagene autoleucel), including a Boxed Warning for immune effector cell-associated enterocolitis (IEC-EC). The decision follows reports from clinical trials and postmarketing surveillance indicating that IEC-EC can occur weeks to months after infusion, presenting with severe diarrhea, abdominal pain, and weight loss—sometimes requiring total parenteral nutrition and immunosuppressive therapy. Fatal outcomes due to gut perforation and sepsis have been documented. The updated prescribing information also includes data from the CARTITUDE-4 trial, which demonstrated a statistically significant overall survival benefit in patients with relapsed and lenalidomide-refractory multiple myeloma. Despite the added risks, FDA maintains that the benefit-risk profile of Carvykti remains favorable. Clinicians are advised to monitor for GI symptoms and manage them promptly to mitigate serious complications.

Source:

FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.). [News release]. 2025. https://www.fda.gov/safety/medical-product-safety-information/fda-approves-labeling-changes-include-boxed-warning-immune-effector-cell-associated-enterocolitis