On 28 February 2025, Regeneron announced that the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended conditional marketing authorisation of Lynozyfic® (linvoseltamab) for treatment of adults with relapsed and refractory multiple myeloma (R/R MM) who have received at least three prior therapies. Regeneron’s marketing authorisation application for linvoseltamab was accepted by the EMA in February 2024.
Conditional marketing authorisations are granted to medicines which address unmet medical needs. Less comprehensive clinical data than is normally required may support a conditional marketing authorisation where the benefit of immediate availability of the drug outweighs the risk inherent in the fact that additional data are still required.
The positive recommendation for linvoseltamab was based on data from the “LINKER-MM1” trial, which evaluated linvoseltamab in adults with R/R MM.
Earlier in February 2025, the FDA accepted Regeneron’s resubmitted BLA for linvoseltamab. The FDA’s target action date is 10 July 2025.