EU regulator mandates label updates on CAR-T cancer therapies (updated)

2Seventy Bio

14/06/2024 16:07

(Adds details in paragraphs 2 & 4, background throughout)
       June 14 (Reuters) - The European health regulator said
on Friday product information for a class of cancer therapies
known as CAR-T treatments would be required to highlight risk of
secondary blood cancers in patients who use them, ending a
five-month safety review.
    The European Medicines Agency's (EMA) mandate, which echoes
the one issued by the U.S. health regulator in April, requires
manufacturers of CAR-T therapies to include information on their
label concerning the risk of a new cancer that begins in a type
of white blood cells called T-cells.
    The treatments, chimeric antigen receptor T-cell therapies
or CAR-T, generally involves extracting immune
response-generating T-cells from a patient, re-engineering them
to attack cancer and infusing them back into the body.
    The EMA's Pharmacovigilance Risk Assessment Committee (PRAC)
evaluated data on 38 cases of secondary T-cell cancers in
patients who received CAR-T therapy and identified seven cases
where the therapy was involved in disease development. 
   The committee had announced a safety review in January on
therapies including Bristol Myers Squibb's  BMY.N 
Breyanzi and its partnered therapy with 2seventy bio  TSVT.O ,
Abecma, Johnson & Johnson  JNJ.N  and Legend Biotech's  LEGN.O 
Carvykti, Novartis'  NOVN.S  Kymriah, and Gilead Sciences'
 GILD.O  Tecartus and Yescarta.

 (Reporting by Mariam Sunny in Bengaluru; Editing by Shailesh
Kuber)
 ((Mariam.ESunny@thomsonreuters.com;))