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

2Seventy Bio

23/01/2024 01:34

(Adds details from FDA's letters in paragraphs 7-8)
       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.
    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.
    Since 2017, six CAR-T cell therapies have been approved by
the FDA, and all are for the treatment of blood cancers,
including lymphoma and some forms of leukemia.
    The FDA said in its letters to the companies on Monday that
since the approval of the therapies, it had identified adverse
events and clinical trial reports describing T-cell malignancies
following the treatment. 
    The health regulator said it considered the risk of T-cell
malignancy, which refers to a group of blood disorders including
lymphoma and leukemia, resulting in hospitalization and death,
to be applicable to all therapies in the category. 
    Gilead Sciences, Johnson & Johnson, Novartis, Bristol Myers
Squibb, 2seventy bio and Legend Biotech did not immediately
respond to Reuters' request for comments. 

        

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