Linvoseltamab is intended for use in MM patients who have undergone a minimum of four lines of therapy previously or those who received three lines of treatment and are refractory to the last therapy line.
A decision on the approval from the US regulator for the therapy is expected on 10 July 2025.
The FDA’s BLA acceptance follows the resolution of third-party fill/finish manufacturing concerns raised by the agency in the prior BLA submission.
Regeneron’s latest application is backed by data from the multicentre, dose-escalation, and dose-expansion Phase I/II LINKER-MM1 trial in 282 subjects.
The concluded Phase I part of this trial evaluated the therapy’s tolerability, dose-limiting toxicities, and safety at nine different dose levels.
Furthermore, the Phase II dose-expansion portion, which is ongoing, is evaluating the anti-tumour activity and safety of the candidate with objective response rate as the primary endpoint.
The therapy, as a single agent as well as in conjunction with other treatments across several lines of therapy in MM, is being studied in a clinical development programme.
This includes investigating its use in earlier treatment lines, and in plasma cell precursor disorders.
An investigational BCMAxCD3 bispecific antibody, linvoseltamab is tailored to connect B-cell maturation antigen on myeloma cells with a cluster of differentiation 3 (CD3)-expressing T cells, to trigger T-cell activation and cancer cell destruction.
In the US, linvoseltamab received fast track designation from the FDA to treat R/R MM.