US FDA may delay decision on Bristol Myers-2seventy bio cancer therapy (updated)

2Seventy Bio

20/11/2023 13:30

(Adds background in paragraphs 5 & 6, share movement in
paragraph 4)
       Nov 20 (Reuters) - The U.S. health regulator will not
meet its Dec. 16 deadline on the use of Bristol Myers Squibb
 BMY.N  and partner 2seventy bio's  TSVT.O  blood cancer therapy
in earlier lines of treatment as it plans to seek the advice of
independent experts before making a decision, the companies said
on Monday.
    In 2021, the U.S. Food and Drug Administration (FDA) had
approved the cell therapy Abecma, developed along with partner
2seventy bio  TSVT.O , as a treatment for adult patients with
multiple myeloma after four or more prior lines of therapies did
not show improvement in patients.
    The FDA has not yet confirmed when the advisory panel would
meet, the companies said.
    Shares of Bristol Myers Squibb fell 4% and those of 2seventy
bio slid 8% in premarket trading.
    The marketing application for the cell therapy was based on
data from a late-stage study that showed significant reduction
in the risk of disease progression or death in patients on
Abecma compared to standard regimens.
    Bristol Myers Squibb and 2seventy bio said they look forward
to continuing discussions with the FDA to reinforce the
potential of Abecma.
    The FDA usually follows the recommendations of its advisory
panels but is not obligated to do so.

 (Reporting by Khushi Mandowara in Bengaluru; Editing by Sriraj
Kalluvila and Shailesh Kuber)
 ((Khushi.Mandowara@thomsonreuters.com;))