11 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.

• CAR-T Cell Therapy Cancer Risks May Drop Off After Two Weeks of Therapy: Study

  August 15, 2024

  Tyler New

  A new study has found the risk of developing secondary cancers after receiving CAR-T cell therapy may drop drastically after the first two weeks.

• CAR-T Clinical Trial Results Indicate 60% of Patients Suffered Adverse Effects, Including One Patient Death

  July 3, 2024

  Irvin Jackson

  The death of a patient using an experimental CAR-T drug is under investigation after early clinical trials showed 60% of participants suffered adverse reactions to the medication.

• 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.

• FDA Requires CAR-T Cancer Warnings Be Added For All Drugs in the Class

  January 24, 2024

  Irvin Jackson

  The FDA is requiring black box warnings on six CAR-T treatments due to an increased risk of potentially fatal cancer.

• FDA Adds Black Box Cancer Warning to Carvykti Car-T Treatment

  December 27, 2023

  Irvin Jackson

  The FDA is requiring the CAR-T cancer treatment Carvykti to carry a black box label warning, alerting the medical community and patients to the risks of secondary cancer.

• Investigation Into CAR-T Cell Treatments Reveals New Data on Patient Deaths, Effectiveness

  December 13, 2023

  Katherine McDaniel

  A new study warns of a number of potential side effects and health risks linked to CAR-T drugs used to treat blood cancers like multiple myeloma,

• FDA Investigating Secondary Cancer Risks From CAR-T Cell Treatments

  November 30, 2023

  Katherine McDaniel

  Officials are investigating a potential link between certain blood cancer treatments and the development of new, more severe cancers that may result in adverse health outcomes.