Washington: The U.S. Food and Drug Administration said on Thursday cancer therapies that use CAR-T technology will require changes to the so-called “boxed warning” to highlight the serious risk of T-cell blood cancer in patients who use these therapies.
The health regulor has required related updates to other sections of the label such as warnings and precautions, postmarketing experience, patient counseling information and medication guide.
The agency said patients and clinical trial participants receiving treatment with these products should be monitored life-long for secondary malignancies and the manufacturer should be notified in the event of a new malignancy.
In January, the FDA asked a host of drugmakers including Gilead Sciences Johnson & Johnson and Novartis to add a boxed warning to their CAR-T cancer therapies, as it received reports of patients developing a type of T-cell blood cancer after being treated with them.
The other cancer therapies include Bristol Myers Squibb’s Breyanzi and its therapy, Abecma, with partner 2seventy bio, J&J unit Janssen and Legend Biotech’s Carvykti, Novartis AG’s Kymriah, and Gilead unit Kite’s Tecartus and Yescarta.
