On 11 February 2025, Regeneron announced that the US FDA has accepted for review its resubmitted Biologics Licence Application (BLA) for linvoseltamab. Linvoseltamab, a BCMAxCD3 bispecific antibody, is indicated for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least four lines of therapy, or those who have received three prior lines of therapy and are refractory to the last line of therapy. The FDA’s target action date is 10 July 2025.
According to Regeneron, the BLA was resubmitted following certain manufacturing (third party fill/finish) issues previously raised by the FDA and which have now been resolved.
Linvoseltamab is also under review in Europe, with Regeneron’s marketing authorisation application (MAA) having been accepted by the EMA in February 2024.