Lynozyfic (linvoseltamab-gcpt) is a bispecific antibody that recently received accelerated approval from the U.S. Food and Drug Administration (FDA) for treating relapsed or refractory multiple myeloma (RRMM).
Mechanism of action:
Lynozyfic functions as a bispecific T-cell engager. It binds to both the B-cell maturation antigen (BCMA) found on multiple myeloma cells and the CD3 protein on T-cells. This acts like a bridge, bringing the T-cells into close proximity with the cancerous myeloma cells, thereby activating the T-cells to identify and eliminate them
Administration:
Intravenous infusion.
Dosing:
Includes a “step-up” phase followed by weekly, then bi-weekly doses. A response-adapted schedule allows for potential every-four-week dosing for certain patients.
Clinical Trial Results:
LINKER-MM1 Showed a 70% Objective Response Rate (ORR), with 45% achieving a complete response (CR) or better. The median time to response was under one month.
Safety Information:
Includes a Boxed Warning for serious risks like cytokine release syndrome (CRS) and neurologic toxicities.
Common Side Effects:
Include muscle and bone pain, CRS, cough, and fatigue.