The US Food and Drug Administration (FDA) has delayed the assessment of the supplemental biologics licence application (sBLA) of Abecma (idecabtagene vicleucel) for treating heavily pre-treated relapsed or refractory multiple myeloma.
The FDA had informed and 2seventy bio that the agency will not be able to provide a decision on the sBLA by the Prescription Drug User Fee Act (PDUFA) target action date of 16 December, as per a 20 November .
In 2021, the FDA the drug as a fifth-line therapy for relapsed or refractory multiple myeloma. The companies are seeking approval for Abecma as an earlier line of therapy for triple-class exposed multiple myeloma.
Abecma is a B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR) T-cell therapy. Abecma鈥檚 sales have been a concern, with 2seventybio downsizing in light of low projected sales. The drug is forecasted to generate less than the $470m-$570m range that was previously projected, as per a 12 September .
There has been increased competition in the heavily pre-treated relapsed or refractory multiple myeloma market. In February 2022, the FDA approved Janssen鈥檚 BCMA directed CAR T-cell therapy, Carvykti (ciltacabtagene autoleucel) as a fifth-line therapy for multiple myeloma. The multiple myeloma market is forecasted to generate $21.6bn in sales across the eight major pharmaceutical markets (US, France, Germany, Italy, Spain, UK, Japan, and China), as per .
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By GlobalDataAbecma鈥檚 sBLA is supported by the data from the Phase III KarMMa-3 trial (NCT03651128). The study met its primary endpoint by demonstrating improvement in progression-free survival (PFS) and reduction in the risk of disease progression, compared to standard regimens.
As per the results, participants in the Abecma group had a median PFS of 13.3 months at a median follow-up of 18.6 months, compared to the PFS of 4.4 months in the standard regimen group. A complete response was seen in 39% and 5% of the Abecma and standard treatment group participants, respectively.
Grade 3 or 4 adverse events were seen in 93% and 75% of the Abecma and standard treatment group participants, respectively. In the Abecma group, 88% of the participants observed cytokine release syndrome, with grade 3 or higher events seen in 5% of the patients. The final PFS and interim overall survival data from the KarMMa-3 study will be presented at the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition on 11 December.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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