US FDA staff flag safety concerns from J&J, Bristol's CAR-T therapies

2Seventy Bio

13/03/2024 12:47

March 13 (Reuters) - The U.S. Food and Drug
Administration's staff reviewers on Wednesday raised safety
concerns over the use of Johnson & Johnson's  JNJ.N  and
Bristol-Myers Squibb's  BMY.N  cancer therapies as earlier
treatments for blood cancer patients. 
    Staff reviewers said that the pattern of early deaths
observed in patients treated with both the therapies in their
respective trials raised uncertainty about their overall
survival benefit. 
    The therapies - J&J's Carvykti and Bristol Myers' Abecma -
are approved by the FDA to treat patients with multiple myeloma
who have received at least four prior lines of treatment.
    
    
   
    

 (Reporting by Sneha S K and Bhanvi Satija in Bengaluru; Editing
by Shailesh Kuber)
 ((Sneha.SK@thomsonreuters.com;))