US FDA declines to approve Atara Biotherapeutics' cancer therapy (updated)

Atara Biotherapeutics

16/01/2025 13:56

(Adds details in paragraphs 2 and 5)
       Jan 16 (Reuters) - The U.S. Food and Drug Administration
on Thursday declined to approve Atara Biotherapeutics'  ATRA.O 
therapy for the treatment of patients with a rare cancer that
develops after organ or stem cell transplants.
    The company said the FDA's decision was based on
observations made during an inspection of a third-party
manufacturing facility.
    Atara was seeking approval for the therapy, chemically
called tabelecleucel, to treat patients with Epstein-Barr virus
positive post-transplant lymphoproliferative disease (EBV+
PTLD). 
    The rare condition causes uncontrolled growth of a type of
white blood cells, known as B-cells, and leads to the formation
of tumors.
    The company said if it does not secure enough funding by the
first quarter of 2025, it intends to suspend all of its CAR-T
cell therapy programs and significantly reduce company expenses
and activities to only those that support the approval of
tabelecleucel.
    Trading in the California-based company's shares was halted
premarket.
    

 (Reporting by Kamal Choudhury and Christy Santhosh in
Bengaluru; Editing by Shilpi Majumdar)
 ((Kamal.Choudhury@thomsonreuters.com))