FDA approves Linvoseltamab (rivosetantumab) for the treatment of relapsed or refractory multiple myeloma

On July 2, 2025, the U.S. Food and Drug Administration (FDA) approved Linvoseltamab (rivosetantumab; trade nameLynozyfic), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T cell engager, specifically indicated for the treatment of adult patients with relapsed or refractory multiple myeloma (R/RMM). These patients had previously received at least four different treatments, including proteasome inhibitors (PIs), immunomodulators (IMiDs), and anti-CD38 monoclonal antibodies.

The efficacy and safety of linvoseltamab were evaluated inLINKER-MM1 (NCT03761108) clinical trial, an open-label, multicenter, multi-cohort study. Participants were all patients who had received at least three previous treatments, including PI, IMiD and anti-CD38 antibody. It should be noted that this trial excluded patients who had previously received BCMA-guided bispecific antibody therapy, bispecific T cell-mediated therapy, and BCMA CAR-T cell therapy. The active population consisted of 80 patients who had received at least four treatments before participating.

According to the results of the study,linvoseltamab’s objective response rate (ORR) reached 70% (95% confidence interval: 59%-80%). Median follow-up of responders was 11.3 months, and duration of response (DOR) was 89% (95% CI: 77%-95%) at 9 months and 72% (95% CI: 54%-84%) at 12 months.

The prescribing information for linvoseltamab contains a boxed warning for life-threatening cytokine release syndrome (CRS) and neurotoxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). Due to the risk of CRS and neurotoxicity (including ICANS), linvoseltamab is only available through a restricted program (called Lynozyfic REMS) and requires the implementation of a risk assessment and mitigation strategy. In addition, other warnings and precautions are included in the prescription, such as infection, neutropenia, hepatotoxicity, and embryo-fetal toxicity.

In terms of dosage,The recommended dosage of linvoseltamab is in ascending doses of 5 mg, 25 mg and 200 mg, followed by 200 mg administered weekly for a total of 10 times. At or after Week 24, if the patient achieves and maintains a very good partial response or better partial response and receives at least 17 treatments of 200 mg, a reduction in dosing frequency to 200 mg every 4 weeks may be considered.

Reference materials:https://en.wikipedia.org/wiki/Linvoseltamab