The European Commission (EC) has granted conditional marketing approval to Regeneron Pharmaceuticals’ bispecific antibody Lynozyfic (linvoseltamab) for adults with relapsed and refractory (R/R) multiple myeloma (MM).
The approval targets patients who have undergone a minimum of three previous therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-cluster of differentiation 38 (CD38) monoclonal antibody, and have shown disease progression on the final therapy.
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Lynozyfic acts by connecting B-cell maturation antigen (BCMA) on MM cells with T cells that express CD3, thereby promoting T-cell activation and cancer-cell destruction.
The antibody is the first BCMAxCD3 treatment approved for administration every four weeks, as a result of a response-adapted regimen achieving a very good partial response (VGPR) or better after a minimum of 24 weeks of therapy.
The EC’s decision is underpinned by the outcomes from the pivotal multicentre LINKER-MM1 trial at the 200mg dose of the antibody.
This trial reported a 71% objective response rate, with half of the subjects achieving a complete response (CR) or better, as assessed by an independent review committee. The rate of minimal residual disease negativity in individuals achieving a CR or stringent CR was found to be 41%.
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By GlobalDataThe trial is ongoing, with more than 300 subjects with R/R MM enrolled.
Linvoseltamab’s clinical development programme is exploring its use both as a single agent and in conjunction with other treatments across various therapy lines in MM, including previous lines of treatment and plasma cell precursor disorders.
The Food and Drug Administration is reviewing the biologics licence application for the antibody in the US, with a decision expected by 10 July 2025.
Regeneron Pharmaceuticals president, chief scientific officer and board co-chair George Yancopoulos stated: “Lynozyfic is our second approved bispecific antibody – in this case for relapsed/refractory multiple myeloma patients – reinforcing our relentless commitment to transforming cancer care for those who need it most.
“We are excited by the potential of Lynozyfic and its differentiated clinical profile, dosing, and administration. Given the strength of the data, we are pursuing a robust clinical development programme exploring its use – in earlier lines of therapy as monotherapy and in novel combinations – with the hope of further advancing care for patients.”
Regeneron had previously expanded its manufacturing capabilities through a new agreement with Fujifilm Diosynth Biotechnologies.
