Regeneron's Lynozyfic Secures EU Approval for Multiple Myeloma, Setting Stage for Market Competition

Regeneron Pharmaceuticals has achieved a significant milestone with the European Commission's approval of Lynozyfic (linvoseltamab) for the treatment of relapsed or refractory multiple myeloma. This approval marks a crucial step forward in expanding treatment options for patients who have undergone at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Mechanism of Action and Dosing Regimen

Lynozyfic, a bispecific antibody, operates by bridging B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells, thereby triggering T-cell activation. The drug's innovative response-adapted regimen allows for administration every four weeks in patients who achieve a "very good partial response" or better after 24 weeks of therapy.

Clinical Efficacy and Safety Profile

The LINKER-MM1 trial demonstrated impressive results for Lynozyfic, with 71% of patients experiencing a complete or partial response. The median duration of response was 29 months, with a complete response rate of 50%. These findings underscore the drug's potential to induce complete remission in heavily pretreated patients.

However, the trial also revealed a range of adverse reactions:

• Musculoskeletal pain (52% of patients)
• Cytokine release syndrome (CRS) (46%)
• Diarrhea (39%)
• Anemia (38%)
• Fatigue (36%)
• Pneumonia (32%)
• Upper respiratory tract infection (30%)

Notably, there was only one case of grade 3 CRS and no cases of grade 4 or above CRS reported.

Market Landscape and Future Outlook

Lynozyfic's entry into the European market sets the stage for increased competition in the multiple myeloma bispecific antibody space. Johnson & Johnson's Tecvayli and Pfizer's Elrexfio, both approved in Europe and the United States, have already established a presence in this market segment. In 2024, Tecvayli generated $549 million in sales, while Elrexfio, launched in 2023, reported $133 million in revenue.

Regeneron is still awaiting FDA approval for Lynozyfic in the United States, with a decision target date of July 10. The company's initial filing was rejected last summer due to issues with a third-party manufacturer's facility, which have since been addressed in a re-filed application.

As the multiple myeloma treatment landscape continues to evolve, the introduction of Lynozyfic provides physicians and patients with a new therapeutic option. Dr. Paula Rodriguez-Otero of Spain's Cancer Center Clínica Universidad de Navarra emphasized the importance of having "new therapies with different mechanisms of action" for patients who have relapsed on multiple treatment classes.