FDA Adds Boxed Warning to Johnson & Johnson and Legend Biotech’s CAR-T Therapy Carvykti

October 10, 2025 — Washington, D.C. — The U.S. Food and Drug Administration (FDA) has issued a new safety update for Carvykti (ciltacabtagene autoleucel), a CAR-T cell therapy co-developed by Johnson & Johnson and Legend Biotech, adding a boxed warning to the product label after reports of a rare but serious gastrointestinal adverse reaction.

According to the FDA, several patients treated with Carvykti developed immune effector cell–associated enterocolitis (IEC-EC), a rare but severe inflammatory condition that can cause intestinal perforation and sepsis, with some fatal cases reported. The agency required the manufacturers to update labeling and provide additional guidance for physicians to strengthen gastrointestinal monitoring and risk mitigation during treatment.

Photo courtesy of U.S. Food and Drug Administration

Both Johnson & Johnson and Legend Biotech have stated that they are updating safety materials and physician education, while reaffirming their commitment to patient safety. The FDA emphasized that Carvykti continues to offer meaningful clinical benefit for patients with relapsed or refractory multiple myeloma when used under proper clinical supervision.

This update highlights the growing importance of post-marketing pharmacovigilance in the evolving cell and gene therapy landscape. As the global field advances, manufacturing quality, analytical robustness, and process consistency have become essential to managing product safety across diverse patient populations.

Photo by Diane Serik on Unsplash

A Hillgene spokesperson commented that continuous process optimization and real-time product analytics are crucial to ensuring the safety and stability of immune cell therapy products. “The industry’s next phase will depend not only on clinical innovation but also on scalable, GMP-compliant manufacturing and in-process control. That’s where CDMO partners like Hillgene can contribute to elevating global quality standards,” the company noted.

Source: Reuters, “US FDA adds boxed warning to J&J, Legend Biotech’s cancer therapy Carvykti,” October 10, 2025.