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# FDA Updates Carvykti Labeling With Boxed Warning
- URL: https://www.fdaweb.com/fda-updates-carvykti-labeling-with-boxed-warning/
- Published: 2025-10-10T12:00:00.000Z
- Updated: 2026-09-14T15:23:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160022

FDA has approved new labeling for Janssen Biotech’s Carvykti (ciltacabtagene autoleucel, including a Boxed Warning highlighting the risk of immune effector cell-associated enterocolitis (IEC-EC), a potentially life-threatening gastrointestinal complication. The warning comes after the agency reviewed reports from clinical trials and postmarketing data documenting cases of IEC-EC in patients receiving the therapy, an [agency update ](http://FDA has approved new labeling for Janssen Biotech’s Carvykti %28ciltacabtagene autoleucel, including a Boxed Warning highlighting the risk of immune effector cell-associated enterocolitis %28IEC-EC%29, a potentially life-threatening gastrointestinal complication. The warning comes after the agency reviewed reports from clinical trials and postmarketing data documenting cases of IEC-EC in patients receiving the therapy, an agency update says. %28XXINSERT LINKXX%29 Affected patients experienced severe or prolonged diarrhea, abdominal pain, and weight loss, sometimes requiring total parenteral nutrition, it says, adding that in some cases, the condition led to fatal outcomes, including gut perforation and sepsis. Management of IEC-EC often required immunosuppressive therapies such as corticosteroids, along with supportive care.     In addition to the safety update, FDA approved revisions to the product’s Clinical Studies section to include new overall survival data from the CARTITUDE-4 trial, a randomized, multicenter study in adults with relapsed and lenalidomide-refractory multiple myeloma. The trial showed a statistically significant improvement in overall survival for patients treated with CARVYKTI compared to standard therapy, the update says.     Despite the newly identified risks, the agency concluded that the benefits of Carvykti continue to outweigh potential risks for its approved use. FDA %28XXX SUBSTITUTE XXX%29emphasizes %28XXX TENSE XXX%29that ongoing monitoring of CARVYKTI and other biologics remains a priority.)says. Affected patients experienced severe or prolonged diarrhea, abdominal pain, and weight loss, sometimes requiring total parenteral nutrition, it says, adding that in some cases, the condition led to fatal outcomes, including gut perforation and sepsis. Management of IEC-EC often required immunosuppressive therapies such as corticosteroids, along with supportive care.

In addition to the safety update, FDA approved revisions to the product’s Clinical Studies section to include new overall survival data from the CARTITUDE-4 trial, a randomized, multicenter study in adults with relapsed and lenalidomide-refractory multiple myeloma. The trial showed a statistically significant improvement in overall survival for patients treated with Carvykti compared to standard therapy, the update says.

Despite the newly identified risks, the agency concluded that the benefits of Carvykti continue to outweigh potential risks for its approved use. FDA emphasizes that ongoing monitoring of Carvykti and other biologics remains a priority.