Linvoseltamab granted accelerated approval by the FDA for patients with RRMM

On July 2, 2025, the U.S. Food and Drug Administration (FDA) approved linvoseltamab-gcpt, a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and anti-CD38 monoclonal antibody.¹

This approval was based on results from the open-label, multicenter, phase I/II LINKER-MM1 (NCT03761108) trial.¹ The overall response rate (ORR) was 70%, and with a median follow-up of 11.3 months, the estimated duration of response (DoR) was 89% and 72% at 9 months and 12 months, respectively.¹

The linvoseltamab Prescribing Information includes a Boxed Warning for cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS).¹ In the LINKER-MM1 trial, among patients who received linvoseltamab at the recommended dose, the rates of CRS and neurologic toxicity were 46% and 54%, respectively (Grade 3 CRS, <1% and Grade 3/4 neurological toxicity, 8%).¹

Linvoseltamab was previously granted conditional marketing authorization from the European Commission for the treatment of patients with RRMM who received ≥3 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, with progression on the last therapy.