CAR-T Drug for Myeloma Hit With New Boxed Warning

CAR-T Drug for Myeloma Hit With New Boxed Warning

(MedPage Today) -- Ciltacabtagene autoleucel (cilta-cel; Carvykti) for multiple myeloma has a new boxed warning for immune effector cell-associated enterocolitis (IEC-EC), the FDA announced on Friday. Trials and postmarketing adverse event data...

FDA Updates Boxed Warning for Cilta-Cel Following Reports of Immune Effector Cell–Associated Enterocolitis

The move emphasizes the need for vigilant monitoring.

FDA Adds Boxed Warning for IEC-EC to CAR-T Drug

The FDA adds a new boxed warning for immune effector cell-associated enterocolitis with Carvykti, but says the overall benefit continues to outweigh the potential risks for the approved use. Medscape Medical News Source link : https://www.medscape.com/viewarticle/fda-adds-boxed-warning-immune-effector-cell-associated-2025a1000rkg?src=rss Author : Publish date : 2025-10-13 19:45:00 Copyright for syndicated content belongs to the linked Source. Th…

FDA Updates Boxed Warning for Cilta-cel to Address Risk of IEC-Associated Enterocolitis

The U.S. Food and Drug Administration (FDA) has updated […] The post FDA Updates Boxed Warning for Cilta-cel to Address Risk of IEC-Associated Enterocolitis first appeared on GeneOnline News. The post FDA Updates Boxed Warning for Cilta-cel to Address Risk of IEC-Associated Enterocolitis appeared first on GeneOnline News.

FDA Adds Boxed Warning to Carvykti Over Risk of Fatal Intestinal Disorder

The FDA has updated the labeling for Johnson & Johnson and Legend Biotech’s Carvykti, a CAR-T cell therapy for multiple myeloma, to include a boxed warning about the risk of immune effector cell-associated enterocolitis (IEC-EC). This serious intestinal inflammatory disorder has been observed in patients within weeks or months after receiving Carvykti, with symptoms including diarrhea, abdominal pain, and weight loss. IEC-EC can be fatal, partic…

Carvykti Black Box Warning About Gastrointestinal Risks Added By FDA

New warning comes amid existing concerns that the entire class of CAR-T medications could increase the risks of cancer. The blood cancer treatment Carvykti has been linked to an increased risk of potentially deadly gastrointestinal inflammation by federal regulators, who have determined the risks require the strongest label warning a medication can carry. The…