(Reuters) -The U.S. Food and Drug Administration approved on Friday labeling changes for the blood cancer therapy of Johnson & Johnson and its partner Legend Biotech to include a warning for a potentially fatal gastrointestinal condition.
Such a warning appears on the medicine’s label and is the most serious issued by the FDA.
The FDA said it received reports that some patients treated with Carvykti developed a serious gut inflammation called IEC-EC, which in some cases led to life-threatening complications like bowel perforation and sepsis.
Reports were received from clinical trials and postmarketing adverse event data, the FDA said.
IEC-EC is a form of inflammation of the intestines triggered by the immune system. It was observed weeks to months after CAR-T therapy treatment with Carvykti in both clinical trials and after approval, the regulator said.
Symptoms included persistent diarrhea, stomach pain and weight loss, often requiring intensive care and immune-suppressing drugs.
A spokesperson for Johnson & Johnson said: “With more than 8,500 patients treated, the overall benefit/risk for Carvykti continues to be favorable, demonstrating durable responses with statistically significant progression-free survival and overall survival benefits.
“The Carvykti label was also updated to include data showing a superior overall survival benefit versus standard therapies… at nearly three years of follow-up in patients receiving one to three prior lines of therapy.”
Carvykti was first approved in February 2022 and received expanded approval in April 2024 for adults with relapsed or refractory multiple myeloma who had received at least one prior line of therapy.
Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, found in the bone marrow.
The FDA also updated the “clinical studies” section of the drug’s prescribing information to include overall survival data from the late-stage trial.
The interim data of the late-stage study showed a statistically significant improvement in survival for patients receiving Carvykti compared to those on standard therapy, with a median follow-up of 33.6 months.
Despite the new safety concerns, the FDA said the overall benefit of Carvykti continues to outweigh the risks for its approved use.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Alan Barona and Muralikumar Anantharaman)
