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The FDA approved updated labeling for Carvykti (ciltacabtagene autoleucel, Janssen Biotech) to include a new boxed warning for immune effector cell-associated enterocolitis (IEC-EC). 

Carvykti is a type of CAR T-cell therapy used to treat multiple myeloma. 

IEC-EC is a severe inflammation of the intestines that can occur after certain immunotherapies, including CAR T-cell therapy. 

The label changes were prompted by reports from both clinical trials and postmarketing adverse event data of patients developing IEC-EC following Carvykti therapy.

Patients with IEC-EC after Carvykti therapy presented with prolonged or severe diarrhea, abdominal pain, and weight loss, in some cases necessitating total parenteral nutrition. In severe instances, IEC-EC has been associated with fatal outcomes from gut perforation and sepsis. 

Onset has been documented weeks to months after infusion, the FDA said. 

Management of IEC-EC typically involved supportive care, total parenteral nutrition if needed, and immunosuppressive therapy, such as corticosteroids.

For patients with treatment-refractory IEC-EC, additional work-up should be considered to exclude gastrointestinal T-cell lymphoma, which has been reported in the postmarketing setting, the FDA advised. 

In addition to the boxed warning, the labeling changes extend to the warnings and precautions and adverse reactions — postmarketing experience sections of the prescribing information and medication guide.

Despite the updated labeling to reflect the potential risk of IEC-EC, the FDA has determined that the overall benefit of Carvykti “continues to outweigh the potential risks for the approved use, including overall survival benefit in patients treated with Carvykti,” the agency said.

In the CARTITUDE-4 trial, there was a statistically significant overall survival benefit for Carvykti over standard therapy in relapsed and lenalidomide-refractory multiple myeloma (with a median follow-up of approximately 33.6 months). The FDA also approved updates to the clinical studies section of the prescribing information to include the overall survival data from this trial. 

The FDA encourages clinicians to remain vigilant for gastrointestinal symptoms in patients who are being treated with Carvykti and to manage suspected IEC-EC in consultation with gastroenterology and infectious disease specialists. 

The FDA also advises that suspected adverse events be reported to MedWatch.