5 results

• Carvykti Black Box Warning About Gastrointestinal Risks Added By FDA

  October 13, 2025

  Irvin Jackson

  The FDA is warning that the CAR-T therapy Carvykti is linked to an increased risk of a gastrointestinal inflammation that has led to deaths due to gut perforation and sepsis.

• FDA Raises Concerns Over Carvykti and Abecma Clinical Trial Deaths Ahead of CAR-T Advisory Hearing

  March 15, 2024

  Irvin Jackson

  The FDA has submitted documents to its cancer drug advisory committee pointing to high death rates and complications among patients given the CAR-T drugs Abecma and Carvykti.

• CAR-T Therapy Drug Cancer Risks Will Be Reviewed at FDA Advisory Committee Meeting Next Month

  February 7, 2024

  Irvin Jackson

  The FDA will hold an advisory committee meeting on March 15 over the safety of some CAR-T therapy drugs, following new black box cancer warning requirements.

• FDA Found 22 Cases of Cancer Linked to CAR-T Treatments: Report

  January 26, 2024

  Irvin Jackson

  The FDA Found 22 cases of cancer potentially linked to CAR-T cell treatments, resulting in the recent addition of black box label warning requirements for the entire class of medications.

• CELLEX Photopheresis System May Cause Pulmonary Embolism, Death, FDA Warns

  February 7, 2018

  Irvin Jackson

  The FDA warns that the Cellex Photopheresis System has been linked to incidents of pulmonary embolism, deep vein thrombosis and death.