FDA Adds Fatal Risk Warning to J&J and Legend Biotech’s Carvykti Cancer Therapy

The U.S. Food and Drug Administration (FDA) has updated the safety labeling for Carvykti, the multiple myeloma therapy developed by Johnson & Johnson and Legend Biotech, to include a warning about a rare but potentially fatal gastrointestinal condition. This marks the most serious type of FDA-issued warning, reflecting concerns over reports of immune effector cell–associated enterocolitis (IEC-EC).

According to the FDA, cases of IEC-EC have been observed both in clinical trials and among patients treated after Carvykti’s market approval. The condition, characterized by severe inflammation of the intestines triggered by the immune system, can cause life-threatening complications such as bowel perforation and sepsis. Symptoms reported include persistent diarrhea, abdominal pain, and weight loss, often requiring hospitalization and treatment with immune-suppressing drugs.

Carvykti, a CAR-T cell therapy, was first approved in February 2022 and gained expanded approval in April 2024 for adults with relapsed or refractory multiple myeloma who had undergone at least one prior line of therapy. Despite the newly identified risks, the FDA emphasized that the overall benefits of Carvykti continue to outweigh the potential dangers for its approved uses.

A Johnson & Johnson spokesperson reaffirmed the therapy’s positive clinical profile, noting that over 8,500 patients have been treated and that Carvykti has shown durable responses with statistically significant improvements in progression-free and overall survival. The updated label now includes new data demonstrating superior overall survival compared to standard treatments after a median follow-up of 33.6 months.

While the warning underscores ongoing safety monitoring for advanced immunotherapies, Carvykti remains a promising treatment option for multiple myeloma, an incurable blood cancer that affects plasma cells in the bone marrow.