After reports of serious adverse events in clinical trials and post-marketing studies, the US Food and Drug Administration (FDA) has launched in investigation into whether CAR-T immunotherapies can cause lymphoma in some patients.
The pricey treatments have been touted as potential life-savers for how they can reprogramme a patient’s immune cells to attack cancer cells, but they carry the risk of secondary cancers, which prompted the FDA to include a warning in prescribing information and to require 15-year safety studies upon approval.
The first CAR-T treatment was approved in 2017, reports Axios.
“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 hospitalisation and death, and is evaluating the need for regulatory action,” the agency said last week.
Regulators said the risk was connected to all six approved CAR-T treatments: Bristol Myers Squibb’s Abecma and Breyanzi; Johnson & Johnson and Legend Biotech’s Carvykti; Novartis’s Kymriah, and Gilead’s Tecartus and Yescarta.
The FDA said it received reports of T-cell malignancies, including including lymphoma in the re-engineered cells.
It has received 19 reports since its first approval of CAR-T therapies, including 14 from the agency’s adverse event system, Endpoints News reported.
Certain gene therapies like CAR-T use viral vectors to re-engineer the body’s cells to attack cancer cells. They’ve worked well in blood cancers because the target may be more accessible than in solid tumours.
But they still carry the risk of “off-target” edits that focus on the wrong genetic sequence and could increase the risk of developing another cancer.
Axios article – FDA probes safety of CAR-T therapies (Open access)
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CAR-T cell therapy for leukaemia associated with less dangerous side effects
FDA approves CAR-T cell therapy for some large B-cell lymphomas
New T-cell therapy has potential to kill most human cancer types – animal study