EMA valida la domanda di autorizzazione per linvoseltamab da parte di Regeneron come trattamento del mieloma multiplo recidivato o refrattario

Regeneron has announced that the EMA has validated its Margeting Authorization Application for linvoseltamab for the treatment of adult patients with relapsed/refractory (r/r) multiple myeloma (MM) who have progressed after at least three prior therapies.

The MAA is supported by data from a Phase 1/2 pivotal trial (LINKER-MM1) investigating linvoseltamab in r/r MM.

LINKER-MM1 is an open-label, multicenter Phase 1/2 dose-escalation and dose-expansion trial.

A Biologics License Application (BLA) was also submitted to the FDA in December 2023.

Reference link: Regeneron press release