9 results

• Skysona Blood Cancer Side Effects Lead to New FDA Restrictions

  August 11, 2025

  Martha Garcia

  The FDA has added a black box warning to the gene therapy drug Skysona after discovering more patients developed blood cancer than previously believed.

• Skysona Blood Cancer Risks Result in FDA Investigation Into Gene Therapy Treatment

  December 2, 2024

  Martha Garcia

  Federal health officials are investigating a potential link between the gene therapy Skysona and blood cancers, after clinical trials identified several patients who developed serious side effects in the months following treatment, including blood cancers and leukemia.

• 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.

• 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.

• 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.