FDA investigating whether CAR-T, a treatment for cancer, can also cause lymphoma

The Food and Drug Administration said Tuesday that it is investigating whether CAR-T therapy, which uses genetically modified white blood cells to attack tumors, can in rare cases cause lymphoma, a blood cancer.

“Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory action,” the agency said in a statement.

The agency noted that it is investigating reports of T cell lymphoma, including cancer cells carrying the engineered T cells, in patients who received CAR-T therapy. Experts in the field, which has produced multiple approved products to treat blood cancer, expressed surprise and puzzlement at the announcement, saying that they had not previously seen data about the risk.

STAT+ Exclusive Story

Already have an account? Log in

This article is exclusive to STAT+ subscribers

Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+.

Already have an account? Log in

Already have an account? Log in

Individual plans

Group plans

Monthly

$39

Totals $468 per year

$39/month Get Started

Totals $468 per year

Starter

$30

for 3 months, then $39/month

$30 for 3 months Get Started

Then $39/month

Annual

$399

Save 15%

$399/year Get Started

Save 15%

11+ Users

Custom

Savings start at 25%!

Request A Quote Request A Quote

Savings start at 25%!

2-10 Users

$300

Annually per user

$300/year Get Started

$300 Annually per user

View All Plans

Get unlimited access to award-winning journalism and exclusive events.

Subscribe

Log In