April 18 (Reuters) - 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 ( GILD ), Johnson & Johnson ( JNJ ) 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 ( BMY )
Breyanzi and its therapy, Abecma, with partner 2seventy
bio, J&J unit Janssen and Legend Biotech's ( LEGN )
Carvykti, Novartis AG's Kymriah, and Gilead unit Kite's
Tecartus and Yescarta.