FDA approves labeling changes for Janssen’s Carvykti

The US Food and Drug Administration (FDA) on Friday revealed it has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with Carvykti (ciltacabtagene autoleucel), a CAR-T cell therapy from Johnson & Johnson (NYSE: JNJ) subsidiary Janssen.

Reports were received from clinical trials and post-marketing adverse event data. Patients with IEC-EC presented with severe or prolonged diarrhea, abdominal pain, and weight loss requiring total parenteral nutrition. IEC-EC occurred weeks to months following Carvykti infusion. In addition to supportive care and total parenteral nutritional, treatment with various immunosuppressive therapies including corticosteroids were required. IEC-EC was associated with fatal outcomes from gut perforation and sepsis, the FDA noted.

J&J reported second-quarter 2025 aggregate sales of $439 million for Carvykti, representing an 18% quarter-over-quarter increase from $369 million in the first quarter of 2025. The drug is partnered with Legend Biotech (Nasdaq: LEGN), which earned around $35 million in royalties for the second quarter.