EU Approves Lynozyfic for Difficult-to-Treat Multiple Myeloma

Regeneron Pharmaceuticals has received conditional approval from the European Commission for Lynozyfic (linvoseltamab), a new treatment for adults with relapsed and refractory multiple myeloma. This decision provides a new option for patients who have already undergone at least three prior lines of therapy and are experiencing disease progression.

A Novel Bispecific Antibody with Response-Adapted Dosing

Lynozyfic is a bispecific antibody that simultaneously targets BCMA on myeloma cells and CD3 on T cells, triggering the immune system to attack malignant plasma cells. Notably, it is the first BCMAxCD3 therapy to introduce a response-adapted treatment schedule — patients achieving a very good partial response or better after 24 weeks can reduce dosing frequency to once every four weeks.

Promising Results from LINKER-MM1 Trial

Approval was based on results from the LINKER-MM1 study, where Lynozyfic demonstrated strong clinical efficacy. The trial showed an objective response rate of 71%, with 50% of patients reaching complete or stringent complete responses. Among those achieving complete response, 41% had no detectable minimal residual disease. The median duration of response was an encouraging 29 months.

Manageable Safety Profile

Reported side effects included musculoskeletal pain, cytokine release syndrome (CRS), and neutropenia. Most CRS cases were mild or moderate, with no severe (Grade 4) incidents recorded, suggesting a favorable safety profile.

Expanding Hope for Patients

Dr. Paula Rodriguez-Otero of Clínica Universidad de Navarra emphasized Lynozyfic’s potential to induce complete remission even in heavily pretreated patients. Regeneron’s President, George Yancopoulos, highlighted the therapy’s differentiated benefits. With 35,000 new cases of multiple myeloma diagnosed each year in Europe, Lynozyfic represents a meaningful advance for patients with limited remaining treatment options.

Regeneron continues to explore additional applications of this therapy to improve outcomes worldwide.