Regeneron Pharmaceuticals said that the US Food and Drug Administration (FDA) has accepted its biologics licence application (BLA) for priority review of linvoseltamab in the treatment of certain adults with multiple myeloma (MM).
Linvoseltamab is an experimental bispecific antibody. It is intended to connect B-cell maturation antigen on various myeloma cells with CD3-expressing T cells to help T-cell activation and destroy cancer cells.
Regeneron seeks approval for linvoseltamab to treat relapsed/refractory (r/r) MM that has advanced after at least three previous therapies.
The FDA has set itself a target action of 22 August 2024 to take a call on the approval of the drug candidate.
Earlier this month, the European Medicines Agency accepted the marketing authorisation application for the bispecific antibody for review in the same indication.
Regeneron’s BLA with the FDA is supported by data from an ongoing Phase 1/2 clinical trial known as LINKER-MM1. This open-label, multicentre trial enrolled 282 subjects having R/R MM.
The completed Phase 1 dose-escalation part of the study evaluated the safety, tolerability, and dose-limiting toxicities in nine dose levels of linvoseltamab to assess different administration regimens.
The Phase 2 dose expansion part is reviewing the safety and anti-tumour activity of linvoseltamab. It has a primary endpoint of objective response rate.
Linvoseltamab’s clinical development programme consists of a Phase 3 LINKER-MM3 confirmatory trial. The study is currently recruiting patients with R/R MM.
Further planned trials include a Phase 2 trial in high-risk smouldering MM, a Phase 1/2 study in the first-line setting, and a Phase 2 trial in monoclonal gammopathy of unknown importance.
Regeneron also intends to conduct a Phase 1 trial of the combination of linvoseltamab and a Regeneron CD38xCD28 costimulatory bispecific in MM.
