FDA adds new warning to CAR-T therapies

After investigating the safety of CAR-T cell drugs, the FDA decided to include a serious risk on the boxed warnings of six approved immunotherapies. 

Clinical trials and adverse event data found lymphoma and other cancer growth among some CAR-T cell medicines: Abecma (idecabtagene vicleucel), Breyanzi (lisocabtagene maraleucel), Carvykti (ciltacabtagene autoleucel), Kymriah (tisagenlecleucel), Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel). 

Weeks after infusion, patients might develop mature T cell malignancies, including tumors, the agency said April 18. 

The agency's investigation began in November. By January, the FDA quantified the probe and said it was reviewing 22 reports of patients contracting blood cancer. The FDA then called for safety labeling changes before increased mortality rates were discovered in March. 

"Patients and clinical trial participants receiving treatment with these products should be monitored lifelong for secondary malignancies," the FDA said April 18.

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