Oct 10 (Reuters) - The U.S. Food and Drug Administration

approved on Friday labeling changes for the blood cancer therapy

of Johnson & Johnson ( JNJ ) and its partner Legend Biotech ( LEGN )

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 ( JNJ ) 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)