Linvoseltamab-gcpt

(Lynozyfic®)

Lynozyfic®

Drug updated on 7/16/2025

Dosage FormInjection (intravenous; 5 mg/2.5 mL and 200 mg/10 mL single-dose vials)
Drug ClassBispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engagers
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • 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

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Summary
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  • This summary is based on the review of one randomized controlled trial. [1]
  • Lynozyfic (linvoseltamab-gcpt) is indicated for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
  • In patients with RRMM treated with linvoseltamab 200 mg, the overall response rate (ORR) was 71%, with a complete response (CR) rate of 50% and a median duration of response (DOR) of 29.4 months (95% CI, 19.2 to not evaluable); 39% of these patients had high-risk cytogenetics and 28% had penta-refractory disease.
  • Among patients with RRMM treated with linvoseltamab 200 mg, adverse events included cytokine release syndrome (CRS) (Grade 1: 35.0%, Grade 2: 10.3%, Grade 3: 0.9%), neutropenia (Grade 2: 0.9%, Grade 3: 18.8%, Grade 4: 23.1%), anemia (Grade 1: 3.4%, Grade 2: 4.3%, Grade 3: 30.8%), immune effector cell-associated neurotoxicity syndrome (ICANS) (Grade 1: 2.6%, Grade 2: 2.6%, Grade 3: 2.6%), and infections (overall: 74.4%, Grade 3: 33.3%, Grade 4: 2.6%), with infection frequency and severity declining over time.

Product Monograph / Prescribing Information

Document TitleYearSource
Lynozyfic (linvoseltamab-gcpt) Prescribing Information2025Regeneron Pharmaceuticals, Inc., Tarrytown, NY

Randomized Controlled Trials

Document TitleSex DistributionYearSource
Linvoseltamab for Treatment of Relapsed/Refractory Multiple Myeloma
117Subjects
F: 45%
M: 55%
2024Journal of Clinical Oncology

Sex Distribution:

F:45%
M:55%
117Subjects

Year:

2024

Source:Journal of Clinical Oncology