FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma

Regulatory approval: On July 2, 2025, the FDA granted accelerated approval to linvoseltamab-gcpt (Lynozyfic), a BCMA-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma after at least four prior lines including a PI, an IMiD, and an anti-CD38 monoclonal antibody. Approval was supported by ORR and DOR estimates from the open-label LINKER-MM1 trial. The label includes a Boxed Warning for CRS and neurologic toxicity (including ICANS) and requires a REMS.

FDA accelerated approval (July 2, 2025): linvoseltamab-gcpt for R/R multiple myeloma

The FDA granted accelerated approval on July 2, 2025 to linvoseltamab-gcpt (Lynozyfic; Regeneron), a BCMA-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received ≥4 prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody.

Supporting evidence

Efficacy was evaluated in LINKER-MM1 (NCT03761108), an open-label, multi-center, multi-cohort trial. Patients with prior BCMA-directed bispecific antibody therapy, prior bispecific T-cell engaging therapy, or prior BCMA CAR-T therapy were excluded. The efficacy population for the approved setting included 80 patients who had received ≥4 prior lines including PI, IMiD, and anti-CD38 antibody.

  • Primary efficacy endpoint: objective response rate (ORR) by blinded independent review using IMWG criteria
  • ORR: 70% (95% CI, 59–80)
  • Among responders (median follow-up 11.3 months): estimated DOR 89% at 9 months (95% CI, 77–95) and 72% at 12 months (95% CI, 54–84)

Key safety/regulatory notes

The prescribing information includes a Boxed Warning for life-threatening CRS and neurologic toxicity (including ICANS) and requires access via the Lynozyfic REMS. At the recommended dose in LINKER-MM1, CRS occurred in 46% and neurologic toxicity (including ICANS) in 54%; grade 3 CRS <1% and grade 3–4 neurologic toxicity 8%.

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