Linvoseltamab

Linvoseltamab-gcpt is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. In vitro, linvoseltamab-gcpt activated T-cells, caused the release of various proinflammatory cytokines, and resulted in the lysis of multiple myeloma cells.

• LYNOZYFIC is indicated for the treatment of adult 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 anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14) ] .ICD-10: C90.00

• None. None.contraindicated

Premedicate to reduce the risk of CRS and infusion-related reactions (IRR). ( 2.1 , 2.3 ) Administer only as an intravenous infusion. ( 2.1 , 2.6 ) Recommended Dosage ( 2.2 ): Dosing Schedule Day Dose of LYNOZYFIC Step-Up Dosing Schedule Day 1 Step-up dose 1 5 mg Day 8 Step-up dose 2 25 mg Day 15 First treatment dose 200 mg Weekly Dosing Schedule One week after Day 15 treatment dose and once weekly from Week 4 to Week 13 for 10 treatment doses Second and subsequent treatment doses 200 mg Biweekly (Every 2 Weeks) Dosing Schedule Week 14 and every 2 weeks thereafter Subsequent treatment doses 200 mg Patients who have achieved and maintained VGPR or better at or after Week 24 and received at least 17 doses of 200 mg Every 4 Weeks Dosing Schedule At Week 24 or after and every 4 weeks thereafter Subsequent treatment doses 200 mg Patients should be hospitalized for 24 hours after administration of the first step-up dose and for 24 hours after administration of the second step-up dose. ( 2.1 ) See Full Prescribing Information for instructions on preparation and administration. ( 2.6 ) 2.1 Important Administration Instructions Administer LYNOZYFIC intravenously according to the step-up schedule to reduce the incidence and severity of cytokine release syndrome (CRS) [see Dosage and Administration (2.2) ] . Administer only as an intravenous infusion after dilution in 0.9% Sodium Chloride Injection [see Dosage and Administration (2.6) ] . Administer pretreatment medications [see Dosage and Administration (2.3) ] .

Infections : Can cause serious or fatal infections. Monitor patients for signs or symptoms of infection and treat accordingly. ( 5.4 ) Neutropenia : Monitor complete blood cell counts at baseline and periodically during treatment. ( 5.5 ) Hepatotoxicity: Can cause hepatotoxicity. Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. ( 5.6 ) Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. ( 5.7 , 8.1 , 8.3 ) 5.1 Cytokine Release Syndrome (CRS) LYNOZYFIC can cause cytokine release syndrome (CRS), which can be serious or life-threatening. In LINKER-MM1, CRS occurred in 46% (54/117) of patients who received LYNOZYFIC at the recommended dose, with Grade 1 CRS occurring in 35% (41/117) of patients, Grade 2 in 10% (12/117), and Grade 3 in 0.9% (1/117) [see Adverse Reactions (6.1) ] . Thirty-eight percent (45/117) of patients had CRS following step-up dose 1, including 1 patient who experienced Grade 3 CRS; 8% (9/117) had an initial CRS event following a subsequent dose. Seventeen percent (19/113) of patients developed CRS after step-up dose 2, 10% (11/111) developed CRS after the first full 200 mg dose of LYNOZYFIC, and 3.6% (4/110) developed CRS after the second full dose. Recurrent CRS occurred in 20% (23/117) of patients. The median time to onset of CRS from the end of infusion was 11 (range: -1 to 184) hours after the most recent dose with a median duration of 15 (range: 1 to 76) hours.

The following clinically significant adverse reactions are described elsewhere in the labeling: Cytokine Release Syndrome [see Warnings and Precautions (5.1) ] Neurologic Toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome [see Warnings and Precautions (5.2) ] Infections [see Warnings and Precautions (5.4) ] Neutropenia [see Warnings and Precautions (5.5) ] Hepatotoxicity [see Warnings and Precautions (5.6) ] The most common adverse reactions (≥20%) are musculoskeletal pain, cytokine release syndrome, cough, upper respiratory tract infection, diarrhea, fatigue, pneumonia, nausea, headache, and dyspnea. ( 6.1 ) The most common Grade 3 or 4 laboratory abnormalities (≥30%) are decreased lymphocyte count, decreased neutrophil count, decreased hemoglobin, and decreased white blood cell count. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Regeneron at 1-844-467-2998 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Relapsed or Refractory Multiple Myeloma The safety of LYNOZYFIC was evaluated in LINKER-MM1 [see Clinical Studies (14) ] . Patients (n=117) received LYNOZYFIC as step-up doses of 5 mg on Day 1 and 25 mg on Day 8, and the first treatment dose of 200 mg on Day 15.

Lactation: Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on the mechanism of action, LYNOZYFIC may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of LYNOZYFIC in pregnant women to evaluate for a drug associated risk. No animal reproductive or developmental toxicity studies have been conducted with LYNOZYFIC. Linvoseltamab-gcpt causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. In addition, based on the finding of B-cell depletion in non-pregnant animals, linvoseltamab-gcpt can cause B-cell lymphocytopenia in infants exposed to linvoseltamab-gcpt in-utero. Human immunoglobulin (IgG) is known to cross the placenta after the first trimester of pregnancy; therefore, linvoseltamab-gcpt has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus. LYNOZYFIC is associated with hypogammaglobulinemia, therefore, assessment of immunoglobulin levels in newborns of mothers treated with LYNOZYFIC should be considered. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Metabolism

Pharmacokinetic (PK) parameters were evaluated at the recommended dosage in patients with relapsed or refractory multiple myeloma and are presented as geometric mean (CV%) unless otherwise specified. Linvoseltamab-gcpt PK exposures following use of the recommended dosing schedule are presented in Table 9.

• Jul 2, 2025BLABLA761400Rengeneron Pharmaceuticals, Inc.

1. 1Rash518%
2. 2Pain311%
3. 3Cytokine Release Syndrome27.1%
4. 4Death27.1%
5. 5Drug Ineffective27.1%
6. 6Administration Site Extravasation13.6%
7. 7Alanine Aminotransferase Increased13.6%
8. 8Aspartate Aminotransferase Increased13.6%
9. 9Asthenia13.6%
10. 10Body Temperature Increased13.6%
11. 11Chest Pain13.6%
12. 12Chills13.6%
13. 13Covid-19 Pneumonia13.6%
14. 14Disease Progression13.6%
15. 15Drug Effect Less Than Expected13.6%

The 10 most recently updated of 24 ClinicalTrials.gov registrations naming Linvoseltamab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)
  Recruiting · Phase 3 · Interventional · 270 enrolled · Regeneron Pharmaceuticals
  NCT07393282updated 2026-06-10
• Horizon Two: HR NDMM (MMRC-100)
  Recruiting · Phase 2 · Interventional · 300 enrolled · Multiple Myeloma Research Consortium
  NCT07053436updated 2026-06-10
• A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma
  Recruiting · Phase 2 · Interventional · 116 enrolled · Regeneron Pharmaceuticals
  NCT06140524updated 2026-06-04
• Determination 2 - Isatuximab, Iberdomide, Bortezomib and Dexamethasone Induction, Followed by Risk- and Response-Adapted Consolidation and Maintenance Therapy, in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma
  Not yet recruiting · Phase 3 · Interventional · 720 enrolled · Dana-Farber Cancer Institute
  NCT07624513updated 2026-06-03
• A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
  Recruiting · Phase 3 · Interventional · 915 enrolled · Regeneron Pharmaceuticals
  NCT07222761updated 2026-06-01
• Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS)
  Not yet recruiting · Phase 4 · Interventional · 30 enrolled · Regeneron Pharmaceuticals
  NCT07609940updated 2026-05-27
• Expanded Access of Dupilumab in Adults With Severe Immunoglobulin E (EgE)-Mediated Food Allergy Previously Treated With Linvoseltamab
  Temporarily not available · Expanded access · Regeneron Pharmaceuticals
  NCT06631677updated 2026-05-14
• A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
  Recruiting · Phase 1 · Phase 2 · Interventional · 149 enrolled · Regeneron Pharmaceuticals
  NCT05828511updated 2026-05-13
• Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy
  Recruiting · Phase 1 · Interventional · 6 enrolled · Regeneron Pharmaceuticals
  NCT06369467updated 2026-05-05
• BCMA Bispecific Antibody Therapy for Post-BCMA CAR T-Cell Therapy Relapse (RECLAIM)
  Not yet recruiting · Phase 2 · Interventional · 34 enrolled · Medical College of Wisconsin
  NCT07009899updated 2026-05-01

Frequently asked questions

How does Linvoseltamab work?

Linvoseltamab-gcpt is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. In vitro, linvoseltamab-gcpt activated T-cells, caused the release of various proinflammatory cytokines, and resulted in the lysis of multiple myeloma cells.

What is Linvoseltamab used for?

According to FDA labeling, Linvoseltamab carries indications including: LYNOZYFIC is indicated for the treatment of adult 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 anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14) ] .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Linvoseltamab?

Linvoseltamab is classified as Other monoclonal antibodies and antibody drug conjugates, Bispecific B Cell Maturation Antigen-directed CD3 T Cell Engager, B Cell Maturation Antigen-directed Antibody Interactions, CD3-directed Antibody Interactions, CD3 Receptor Agonists, Increased Cellular Death, Increased Cytokine Activity, Increased T Lymphocyte Activation.

What are the brand names for Linvoseltamab?

Linvoseltamab is marketed under brand names including Lynozyfic.

What are the contraindications for Linvoseltamab?

Linvoseltamab labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.