FDA investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous CAR T-cell immunotherapies

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

FDA 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 CAR T-cell immunotherapies.

To access this subscriber-only content please log in or subscribe.

If your institution has a site license, log in with IP-login or register for a sponsored account.*
*Not all site licenses are enrolled in sponsored accounts.

Login Subscribe
Table of Contents

YOU MAY BE INTERESTED IN

Keytruda (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) reduced the risk of event-free survival events by 60% and reduced the risk of death by 50% when given before and after surgery (radical cystectomy) versus surgery alone, the current standard of care, in patients with muscle-invasive bladder cancer who are not eligible for or declined cisplatin-based chemotherapy, according to phase III KEYNOTE-905/EV-303 trial data. 
In April 2025, announcements from the two most influential biomedical agencies in the US, the FDA and the NIH, declared that both will seek to reduce and minimize animal-based testing and experimentation. These declarations sparked joy in some circles, and deep concern in others that was reflected in a 28% fall in the share price of Charles River Labs (NYSE: NYSE:CRL). 

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login