Three regulators in different jurisdictions for Abecma (idecabtagene vicleucel) for earlier use to treat triple-class exposed relapsed and/or refractory multiple myeloma in adult patients.
The US Food and Drug Administration (FDA) has accepted and 2seventy bio鈥檚 supplemental biologics licence application for Abecma.
Jointly developed and commercialised by both companies, Abecma identifies and binds to the B-cell maturation antigen on the surface of the patient鈥檚 myeloma cells.
This will lead to cytokine secretion, CAR T cell proliferation and subsequent cytolytic killing of BCMA-expressing cells.
The regulator has set 16 December 2023 as the prescription drug user fee act date, which is the deadline for the review of new drugs.
Bristol Myers Squibb senior vice-president and cell therapy development head Anne Kerber stated: 鈥淥ur continued focus on bringing Abecma into earlier lines of treatment demonstrates our commitment to increasing treatment options and improving outcomes for patients living with multiple myeloma.
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By GlobalData鈥淭his FDA acceptance marks another step forward in our mission by bringing us closer to offering this potentially transformative, one-time CAR T treatment option to more patients.鈥�
The company鈥檚 Type II variation application for Abecma has been validated by the European Medicines Agency.
Bristol Myers Squibb also announced that its supplemental new drug application for Abecma has been accepted by Japan’s Ministry of Health, Labour and Welfare.
All three regulatory applications were based on the interim data obtained from a randomised, pivotal open-label, controlled, global Phase III KarMMa-3 trial, designed to assess Abecma against standard combination regimens.
Abecma treatment showed improvement in progression-free survival and overall response rate.
Abecma will be used to treat indicated adult patients who have previously received an immunomodulatory agent, an anti-CD38 monoclonal antibody and a proteasome inhibitor.
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