FDA accepts Regeneron’s BLA for linvoseltamab for review

22 Feb 2024
www.pharmaceutical-technology.com
Phase 1Phase 2Priority ReviewFast TrackPhase 3
FDA accepts Regeneron’s BLA for linvoseltamab for review
Preview
Source: Pharmaceutical Technology
The BLA for Regeneron’s linvoseltamab is based on data from the Phase I/II LINKER-MM1 clinical trial. Credit: lev radin / Shutterstock.com.
The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ biologics licence application (BLA) for linvoseltamab to treat multiple myeloma (MM), for priority review.
An investigational bispecific antibody, linvoseltamab is aimed at adults with relapsed/refractory (r/r) MM who have undergone treatment with a minimum of three previous therapies.
A decision on the regulatory approval from the FDA is anticipated by 22 August 2024.
Linvoseltamab’s mechanism involves connecting the B-cell maturation antigen in MM cells to CD3-expressing T-cells, thereby activating the T-cells and promoting the destruction of cancer cells.
The BLA for linvoseltamab is based on data from a current Phase I/II clinical trial known as LINKER-MM1. This open-label, multicentre trial enrolled 282 subjects.
FDA accepts Regeneron’s BLA for linvoseltamab for review
Preview
Source: Pharmaceutical Technology
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FDA accepts Regeneron’s BLA for linvoseltamab for review
Preview
Source: Pharmaceutical Technology
The completed Phase I dose-escalation segment of the trial evaluated the tolerability, safety and dose-limiting toxicities linked to linvoseltamab at nine dose levels and on varying administration schedules.
The ongoing Phase II dose-expansion stage will analyse the anti-tumour efficacy and safety of the therapy.
The clinical development programme for linvoseltamab includes the LINKER-MM3 Phase III confirmatory trial for R/R MM patients, which is currently recruiting participants.
Plans are in place for further trials targeting earlier stages of the disease and different lines of therapy, such as a Phase I/II trial for first-line therapy, a Phase II trial for high-risk smouldering MM, and a Phase II trial for monoclonal gammopathy of undetermined significance.
A Phase I trial is also planned to explore the combination of linvoseltamab with a Regeneron CD38xCD28 costimulatory bispecific in MM treatment.
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