Bristol-Myers Squibb and partner 2seventy bio are facing a delay in their attempt to bring BCMA-directed CAR-T therapy Abecma to the US market as an earlier-line therapy for multiple myeloma, trimming their lead over Johnson & Johnson and Legend Biotech’s rival Carvykti.
The partners have confirmed that the FDA intends to hold an advisory committee on the marketing application, which means it won’t be able to complete its review by the current 16th December deadline.
Abecma (idecabtagene vicleucel) has been approved by the FDA since 2021 for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and was the first anti-BCMA CAR-T to reach the market.
It has since been joined by Carvykti (ciltacabtagene autoleucel), which was approved by the FDA last year for the same fifth-line or later indication.
Moving the use of the CAR-Ts into earlier lines of therapy is viewed as a key to unlocking their sales potential and providing treatment for a much larger pool of patients, whilst also altering the trajectory of their cancer. It has been estimated that there are around 3,000 multiple myeloma patients in the US needing fifth-line or later treatment, rising to 6,000 for fourth-line therapy and 12,000 to 13,000 for third-line.
The delay means that BMS’ window of opportunity to drive take-up of Abecma before Carvykti reaches the market has just shrunk significantly, assuming of course both are eventually approved.
Abecma was filed for approval on the back of the KarMMA-3 study in patients who had failed two to four lines of prior therapy, which showed the treatment cut the risk of disease progression or death by 51% in its first readout. Updated progression-free survival (PFS) and overall survival (OS) data are due to be presented at the American Society of Haematology (ASH) annual meeting next month.
J&J meanwhile filed for approval of Carvykti based on the results of the CARTITUDE-4 trial, which showed a 74% reduction in PFS in patients with multiple myeloma who had received one to three prior lines of treatment. If approved on that basis, Carvykti could be usable one line in front of its rival.
The FDA has set a review date of 5th April for Carvykti, so if Abecma is facing a three-month delay to its review – which is typical – the decision could only be a few weeks apart.
Worldwide sales of Abecma were $69 million in the third quarter of this year, while Carvykti brought in $152 million.
Photo by Justin Veenema on Unsplash
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