US FDA to delay decision on Bristol Myers-2seventy bio cancer therapy
The therapy was originally co-developed by bluebird bio but following its spin-off in 2021 became part of 2seventy's portfolio.
The U.S. health regulator will not meet its Dec. 16 deadline to decide on the expanded use of Bristol Myers Squibb and partner 2seventy bio's blood cancer therapy in earlier lines of treatment as it plans to seek the advice of experts, the companies said on Monday.
The U.S. Food and Drug Administration (FDA) has not yet confirmed when the advisory panel would meet, they added.
The FDA in 2021 had approved the cell therapy Abecma as a treatment for adult patients with multiple myeloma after four or more prior therapies did not show improvement in patients.
The therapy was originally co-developed by bluebird bio but following its spin-off in 2021 became part of 2seventy's portfolio.
The latest 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 who had received two to four prior treatments.
The FDA usually follows the recommendations of its advisers but is not obligated to do so.
Abecma faces competition from Johnson & Johnson and partner Legend Biotech's Carvykti, which was approved for the same indication last year.
The therapies belong to a class of treatments called chimeric antigen receptor T-cell therapies, or better known as CAR-T therapies, which work by harvesting a patient's own disease-fighting T-cells, genetically engineering them to seek out and attack the cancer.
Bristol Myers and 2seventy bio, however, have faced manufacturing constraints, and a month-long planned maintenance shutdown of one of Abecma's manufacturing facility in June had also negatively impacted sales.
In the third quarter, 2seventy bio's Abecma sales declined 8% to $69 million.
