US FDA may delay decision on Bristol Myers-2seventy bio cancer therapy
ReutersUS FDA may delay decision on Bristol Myers-2seventy bio cancer therapy
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
Source: Reuters
