FDA investigating risk of malignancy linked with CAR-T cell therapies

29 November 2023

The US Food and Drug Administration (FDA) yesterday said it has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous chimeric antigen receptor (CAR)-T cell immunotherapies.

The FDA has determined that the risk of T-cell malignancies is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies. T-cell malignancies have occurred in patients treated with several products in the class. Currently approved products in this class (listed alphabetically by trade name) include the following:

Bristol Myers Squibb’s (NYSE: BMY) Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel);
Johnson & Johnson (NYSE: JNJ) and Legend Biotech's (Nasdaq: LEGN) Carvykti (ciltacabtagene autoleucel);
Novartis' (NOVN: VX) Kymriah (tisagenlecleucel); and
Gilead Sciences' (Nasdaq: GILD) Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel).

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK