Drug updated on 7/16/2025
Dosage Form | Injection (intravenous; 5 mg/2.5 mL and 200 mg/10 mL single-dose vials) |
Drug Class | Bispecific 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
Latest News

Summary
- 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 Title | Year | Source |
---|---|---|
Lynozyfic (linvoseltamab-gcpt) Prescribing Information | 2025 | Regeneron Pharmaceuticals, Inc., Tarrytown, NY |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
Linvoseltamab for Treatment of Relapsed/Refractory Multiple Myeloma | 117Subjects F: 45% M: 55% | 2024 | Journal of Clinical Oncology |
Sex Distribution:
F:45%
M:55%
117Subjects
Year:
2024
Source:Journal of Clinical Oncology