New Bispecific T-Cell Engager Approved for Multiple Myeloma

FDA Approves Regeneron Multiple Myeloma Drug With Dosing Edge Over J&J and Pfizer Meds

Bispecific antibodies are already available for treating multiple myeloma. FDA approval of Regeneron Pharmaceuticals’ new drug, Lynozyfic, comes with dosing flexibility that sets it apart from others in its class.

New Bispecific T-Cell Engager Approved for Multiple Myeloma

(MedPage Today) -- The FDA on Wednesday granted accelerated approval to linvoseltamab (Lynozyfic) for relapsed or refractory multiple myeloma after at least four prior lines of therapy. A B-cell maturation antigen (BCMA)-directed bispecific antibody...

Regeneron’s linvoseltamab receives FDA approval for multiple myeloma By Investing.com

Lynozyfic™ (linvoseltamab-gcpt) Receives FDA Accelerated Approval for Treatment of Relapsed or ...

TARRYTOWN, N.Y., July 02, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple…

FDA approves Lynozyfic for relapsed, refractory multiple myeloma

The FDA granted accelerated approval of linvoseltamab-gcpt for certain patients with multiple myeloma.Specifically, the approval is for patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent and an antiCD38 monoclonal antibody.

Immune Markers of Anti-BCMA CAR-T in Myeloma

In recent years, the landscape of multiple myeloma treatment has witnessed transformative advances, notably with the emergence of chimeric antigen receptor T-cell (CAR-T) therapies targeting the B-cell maturation antigen (BCMA). A groundbreaking study published in Nature Communications by Atanackovic et al. delves deeply into the intricate immune correlates associated with two FDA-approved anti-BCMA CAR-T products: […]