Press release
Lynozyfic™ (linvoseltamab) Approved in the European Union for the Treatment of Relapsed/Refractory Multiple Myeloma
Approval of Lynozyfic is based on data showing deep and durable responses in relapsed/refractory multiple myeloma Lynozyfic will provide a new option with
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"Approval of Lynozyfic is based on data showing deep and durable responses in relapsed/refractory multiple myeloma Lynozyfic will provide a new option with convenient dosing and administration to patients who face cycles of relapse and remission TARRYTOWN, N.Y., April 28, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Commission (EC) has granted conditional marketing approval of Lynozyfic™ (linvoseltamab) to treat adults with relapsed and refractory (R/R) multiple myeloma (MM). The indication is specific to those who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy. Lynozyfic is a bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on MM cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing. Lynozyfic is the first BCMAxCD3 therapy approved that can be dosed every four weeks due to a response-adapted regimen if a very good partial response (VGPR) or better is achieved following completion of at least 24 weeks of therapy. The regimen includes monitoring in close proximity of a qualified treatment center for safety during the step-up dosing period (one 24-hour period after the first step-up dose and another 24-hour period after the second step-up dose, if certain safety events occur). “Despite treatment advances, patients with multiple myeloma inevitably endure relapses, reduced responses to subsequent therapies, and increasingly shorter remissions. For those who develop relapsed and refractory disease after having been exposed to the three major drug classes, it’s important to have new therapies with different mechanisms of action like linvoseltamab,” said Paula Rodriguez-Otero, M.D., Department of Hematology, Cancer Center Clínica Universidad de Navarra, Pamplona, Navarra, Spain. “In a clinical trial, linvoseltamab demonstrated compelling and impressive efficacy with the potential for complete remission in this patient population, including those with high disease burden. Furthermore, its response-adapted schedule will provide patients a convenient treatment option.” The EC approval is based on results from the pivotal LINKER-MM1 trial (n=117 at the 200 mg dose of...