The health regulator was expected to make a decision by December 16 on whether to greenlight Abecma, a treatment for multiple myeloma in adults whose cancer returned after already receiving two to four prior regimens.
Abecma is a therapy that recognizes and binds to B-cell maturation antigen (BCMA) on the surface of multiple myeloma cells leading to CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.
The drug is currently approved for multiple myeloma patients who have previously had four or more lines of treatment, which did not show improvement.
After the delay was announced, shares of Bristol Myers Squibb declined more than 2%, while 2seventybio’s plunged by 20%.
Abecma was first co-developed by bluebird bio but became part of 2seventy bio’s portfolio following the company’s spin-off in 2021.
The delayed marketing application was a result of data from a late-stage clinical trial that demonstrated a reduction in disease progression or death in patients who had received two to four previous therapies.
The news comes after a series of challenges for Bristol Myers Squibb and 2seventy bio, including manufacturing difficulties from a shutdown of a facility producing Abecma, which lasted one month.
This year, worldwide sales of Abecma reached $147 million in Q1 but fell to $132 million in the second and declined further to $93 million in the third.
Despite these challenges, both companies have predicted Abecma’s top sales potential at between $2 billion to $3 billion.
Both companies said they are looking forward to continuing discussions with the FDA to reinforce the potential of Abecma.