EC Approves Regeneron's Lynozyfic for Multiple Myeloma Treatment

Regeneron Pharmaceuticals' innovative treatment, Lynozyfic (linvoseltamab), has received conditional marketing approval from the European Commission (EC) for the management of relapsed and refractory multiple myeloma (R/R MM). This approval is specifically for patients who have previously undergone a minimum of three therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Additionally, these patients must have experienced disease progression on their most recent treatment regimen.

Multiple myeloma (MM) is a challenging and currently incurable form of blood cancer, with over 35,000 new cases emerging in Europe each year. While existing treatment options can decelerate the disease's progression, a significant number of patients eventually relapse and require new therapeutic approaches.

Lynozyfic distinguishes itself as a bispecific antibody designed to connect B-cell maturation antigen (BCMA) present on myeloma cells with CD3-expressing T cells. This interaction stimulates T-cell activation, which is crucial for the targeted destruction of cancer cells. The drug's administration schedule is optimized for efficacy, allowing dosing every four weeks for patients who achieve a very good partial response or better after at least 24 weeks of treatment.

The European Commission's approval was heavily influenced by the positive findings from the phase 1/2 LINKER-MM1 trial. This clinical trial revealed an objective response rate of 71% at a median follow-up of 14 months. Impressively, 50% of participants attained a complete response or better, and 63% achieved a very good partial response or better. Among patients who reached a complete or stringent complete response, the minimal residual disease negativity rate was 41%, and the median duration of response extended to 29 months.

In addition to its current approval for R/R MM, Regeneron is actively exploring the potential of Lynozyfic across various stages of MM treatment, including earlier lines of therapy. The company is also investigating its effectiveness in plasma cell precursor disorders. This broad exploration is part of Regeneron's commitment to enhancing therapeutic options and outcomes for MM patients.

George Yancopoulos, Regeneron's president and chief scientific officer, expressed enthusiasm about Lynozyfic's potential, highlighting its unique clinical profile, dosing flexibility, and administration. He emphasized the company's dedication to a comprehensive clinical development program, assessing the drug as a standalone treatment and in combination with other novel therapies. The goal is to advance patient care significantly.

Moreover, Lynozyfic is not only under review in Europe but also being evaluated by the US Food and Drug Administration (FDA) for its application in R/R MM. The FDA's decision is anticipated by July 10, 2025, marking another crucial step in making this promising treatment widely accessible to patients in need.

Regeneron's efforts with Lynozyfic underscore a significant stride in the fight against multiple myeloma, offering hope to patients confronting this challenging disease through innovative and effective treatment options.