Lynozyfic (Linvoseltamab-Gcpt) for Myeloma

Overview
Lynozyfic is approved by the U.S. Food and Drug Administration (FDA) under accelerated approval for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. These prior treatments must include a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Continued approval may depend on confirmation of clinical benefit in ongoing trials. Lynozyfic is also known by its drug name, linvoseltamab-gcpt.

Lynozyfic is a bispecific biologic therapy known as a B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. It is designed to help the immune system recognize and attack multiple myeloma cells by binding to both BCMA on cancerous plasma cells and CD3 on T cells (a type of immune cell).

How do I take it?
Prescribing information states that Lynozyfic is given as an intravenous (IV) infusion. Treatment begins with a step-up dosing schedule to reduce the risk of cytokine release syndrome. Step-up doses are typically given on Day 1 and Day 8, followed by the first full treatment dose on Day 15. Weekly dosing typically continues from Week 4 through Week 13. Starting at Week 14, the drug is given every two weeks. If a person achieves and maintains a very good partial response or better at or after Week 24 and has received at least 17 treatment doses, dosing may switch to every four weeks. Lynozyfic should be administered exactly as prescribed by a healthcare provider.

Side effects
Common side effects of Lynozyfic include musculoskeletal pain, cytokine release syndrome (a potentially severe immune response), cough, upper respiratory tract infection, diarrhea, fatigue, pneumonia, nausea, headache, and dyspnea (difficulty breathing). Common lab abnormalities include decreased lymphocyte count, decreased neutrophil count, decreased hemoglobin, and decreased white blood cell count.

Rare but serious side effects may include severe cytokine release syndrome, neurologic toxicity including immune effector cell-associated neurotoxicity syndrome (ICANS), serious or fatal infections, neutropenia (low neutrophil counts), hepatotoxicity (liver toxicity), and harm to an unborn baby when taken during pregnancy. At time of approval, Lynozyfic is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS) program.

For more information about this treatment, visit:

Lynozyfic (Linvoseltamab-Gcpt) Injection, for Intravenous Use — Regeneron