US FDA requires 'boxed warning' for CAR-T cancer therapies

2Seventy Bio

23/01/2024 01:11

Jan 22 (Reuters) - The U.S. health regulator said on
Monday companies will be required to add a serious warning on
the prescribing information for cancer therapies known as CAR-T,
made by Gilead Sciences  GILD.O , Johnson & Johnson  JNJ.N ,
Novartis  NOVN.S  and others. 
    Last November, the U.S Food and Drug Administration said it
had received reports of patients developing a type of T-cell
blood cancer after being treated with genetically modified cells
known as chimeric antigen receptor T-cell therapies or CAR-T.
    The other cancer therapies include Bristol Myers Squibb's
 BMY.N  Breyanzi and its partnered therapy, Abecma, with
2seventy bio  TSVT.O , J&J unit Janssen and Legend Biotech's
 LEGN.O  Carvykti, Novartis AG  NOVN.S  Kymriah, and Gilead unit
Kite's Tecartus and Yescarta.
    The treatment generally involves extracting disease-fighting
white blood cells known as T-cells from a patient,
re-engineering them to attack cancer and infusing them back into
the body.
    Since 2017, six CAR-T cell therapies have been approved by
the FDA, and all are for the treatment of blood cancers,
including Lymphomas and some forms of leukemia.
    Gilead Sciences, Johnson & Johnson, Novartis, Bristol Myers
Squibb, 2seventy bio and Legend Biotech did not immediately
respond to Reuters' request for comments. 
    The so-called boxed warnings are the strictest warnings
issued by the FDA regarding the potential serious side effect
from the use of a drug.
        

 (Reporting by Gnaneshwar Rajan in Bengaluru; Editing by Sherry
Jacob-Phillips)
 ((Gnaneshwar.Rajan@thomsonreuters.com;))