New Bispecific T-cell Engager Approved for Multiple Myeloma
The FDA has approved linvoseltamab-gcpt for certain patients with heavily pretreated multiple myeloma.
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to linvoseltamab-gcpt (Lynozyfic) for the treatment of adult patients with relapsed or refractory multiple myeloma previously treated with at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
Linvoseltamab-gcpt is a type of immunotherapy, known as a bispecific T-cell engager, that uses a two-headed antibody to bring cancer cells into proximity with T cells. One end of linvoseltamab-gcpt targets the B-cell maturation antigen that is expressed at high levels on multiple myeloma cells, and the other end engages T cells via CD3.
This is the first FDA approval for linvoseltamab-gcpt, which is the third BCMA-targeted bispecific T-cell engager to be approved for this patient population, following teclistamab-cqyv (Tecvayli) and elranatamab-bcmm (Elrexfio).
The approval is based on results from the multicenter, open-label phase I/II LINKER-MM1 trial that enrolled patients with multiple myeloma who had previously received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, and excluded those previously treated with certain BCMA-directed immunotherapies.
Among the evaluable patients who had received at least four lines of prior therapy, 70% (56/80) experienced responses to linvoseltamab-gcpt. An estimated 89% of responses lasted at least nine months, and 72% at least one year.
The recommended administration for linvoseltamab-gcpt begins with step-up doses of 5 mg, 25 mg, and 200 mg, followed by 10 doses of 200 mg weekly and then 200 mg biweekly. Certain patients with durable responses can switch to 200 mg every four weeks after at least 17 doses.
The prescribing information for linvoseltamab-gcpt contains a boxed warning for life-threatening side effects, including cytokine release syndrome and neurological toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS).
Multiple myeloma is a cancer that arises from antibody-producing immune cells called plasma B cells. According to federal statistics, it was estimated that 36,110 individuals would be diagnosed with multiple myeloma and approximately 12,030 patients would die of the disease in the United States in 2025.
The FDA rendered its decision on July 2, 2025. Accelerated approval means that continued approval may be contingent upon a confirmatory trial. Please check this FDA web page for information about any accelerated approvals in oncology that may have been subsequently withdrawn and are no longer FDA-approved. Check this resource for updated information on all therapeutics regulated by the FDA.