FDA Accelerated Approval: Linvoseltamab (Lynozyfic) for Relapsed or Refractory Multiple Myeloma

FDA accelerated approval based on data from the LINKER-MM1 clinical trial with 70% of heavily pretreated patients responding to linvoseltamab-gcpt

Charles H. Weaver, MD
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Home » Multiple Myeloma » FDA Accelerated Approval: Linvoseltamab (Lynozyfic) for Relapsed or Refractory Multiple Myeloma

The FDA has granted accelerated approval to linvoseltamab-gcpt (Lynozyfic) for adults with relapsed or refractory multiple myeloma who have already received at least four prior treatments, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.

Linvoseltamab-gcpt is a bispecific antibody that works by directing the immune system’s T cells to attack multiple myeloma cells. In the phase 1/2 LINKER-MM1 clinical trial, 70% of heavily pretreated patients responded to the drug, with nearly half achieving a complete response or better. Most responses were durable, with 89% of patients maintaining their response at 9 months and 72% at 12 months.

This treatment offers a new option for patients with few remaining alternatives and features a flexible dosing schedule that may reduce treatment burden for those who respond well. However, it also comes with important safety considerations: life-threatening cytokine release syndrome (CRS) and neurologic toxicity, including ICANS, occurred in some patients. Because of these risks, the medication is only available through a restricted program called the Lynozyfic REMS.

For patients with relapsed or refractory multiple myeloma, this approval represents a significant step forward, providing hope for better disease control when other therapies have failed.

The FDA granted linvoseltamab accelerated approval based on these promising early results, with the understanding that further studies will be conducted to confirm its clinical benefit.

Reference

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma

James D. Phase I/II LINKER-MM1 Trial Data Show Depth of Response with Linvoseltamab for Relapsed/Refractory Multiple Myeloma. Applied Clinical Trials. Published June 17, 2024. Accessed July 2, 2025.

A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments. National Library of Medicine. ClinicalTrials.gov Identifier: NCT05137054. Last Updated June 24, 2025. Accessed July 2, 2025. https://clinicaltrials.gov/study/nct05137054

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