Linvoseltamab Gets FDA Greenlight for RRMM

On July 2, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to linvoseltamab-gcpt for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody.

Like teclistamab and elranatamab, linvoseltamab is a bispecific antibody targeting CD3 and B-cell maturation antigen (BCMA). The approval was based on data from the phase 1/2 LINKER‑MM1 trial (NCT03761108) which enrolled 80 heavily pretreated patients with MM. Patients had an objective response rate (ORR) of 70% (95% CI: 59–80) to linvoseltamab monotherapy. The estimated duration of response was 89% at 9 months and 72% at 12 months.

The approval carries a Boxed Warning due to life‑threatening cytokine release syndrome (CRS) and neurologic toxicity including immune effector cell-associated neurotoxicity (ICANS), and is only available under Risk Evaluation and Mitigation Strategy (REMS) program. In clinical studies, CRS occurred in 46% of patients (Grade 3 <1%), and neurologic events occurred in 54% (Grade 3/4 in 8%). Other warnings and precautions for infections, neutropenia, hepatotoxicity, and embryo-fetal toxicity are included in the label.

Linvoseltamab is administered intravenously. Patients should receive premedications and dosing should be stepped up to prevent CRS. Hospitalization is recommended for 24 hours following step-up dose 1 and 2.

FDA announcement. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma. Accessed July 2, 2025.

Linvoseltamab prescribing information. Available at: https://www.regeneron.com/downloads/lynozyfic_fpi.pdf. Accessed July 2, 2025.