FDA Approval Alert: The Need-to-Know | Linvoseltamab in Relapsed/Refractory Multiple Myeloma

In July 2025, the FDA granted accelerated approval to linvoseltamab-gcpt as a treatment for adult patients with relapsed/refractory multiple myeloma who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Data supporting the FDA decision came from the phase 1/2 LINKER-MM1 (NCT03761108) trial.
Linvoseltamab Earns FDA Accelerated Approval for R/R Multiple Myeloma
Article
Jul 2, 2025 4:12 PM
Data supporting the FDA decision came from the phase 1/2 LINKER-MM1 trial.