FDA Updates Labeling for J&J’s CAR-T Cell Therapy Following Reports of Enterocolitis

The Food and Drug Administration recently updated the prescribing information and medication guide for ciltacabtagene autoleucel (Carvykti, Johnson & Johnson) to include a boxed warning for the risk of immune effector cell-associated enterocolitis (IEC-EC). The change follows reports of IEC-EC in both clinical trials and postmarketing data among patients receiving the therapy.

Ciltacabtagene autoleucel, a B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor (CAR) T-cell therapy, is approved for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.

Patients who developed IEC-EC experienced severe or prolonged diarrhea, abdominal pain and weight loss requiring total parenteral nutrition and immunosuppressive therapies. Some cases resulted in fatal outcomes due to gut perforation or sepsis.

FDA emphasized that the overall benefit of ciltacabtagene autoleucel continues to outweigh its risks and advised clinicians managing patients with IEC-EC to follow institutional protocols, including consultation with gastroenterology and infectious disease specialists. In treatment-refractory cases, evaluation for T-cell lymphoma of the gastrointestinal tract should be considered.