Linvoseltamab
LYNOZYFIC
What it isBCMA×CD3 bispecific T-cell–engaging antibody; relapsed or refractory multiple myeloma.
Why this oneIts intravenous delivery distinguishes it from subcutaneous BCMA bispecifics while remaining off-the-shelf unlike CAR-T.
What limits itCytokine release syndrome and ICANS require step-up dosing and monitoring; hypogammaglobulinemia raises infection risk.
FDA-approved for
- Relapsed or refractory multiple myeloma (2025)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Relapsed or refractory multiple myeloma after >=4 prior lines (incl. proteasome inhibitor, immunomodulatory agent, anti-CD38 mAb); accelerated approval | Adults | Step-up: 5 mg (Day 1), 25 mg (Day 8), then 200 mg (Day 15) | 200 mg weekly for 10 doses, then 200 mg every 2 weeks | At/after Week 24, if VGPR or better and >=17 doses of 200 mg: 200 mg every 4 weeks |
Renal No clinically significant differences in mild-moderate renal impairment (CrCl 30-89 mL/min); unknown in severe/ESRD
Hepatic No clinically significant differences in mild hepatic impairment; unknown in moderate-severe
See label tables for restarting after dose delays (dependent on last dose and elapsed time)
Instructions
- Administer only as an intravenous infusion after dilution in 0.9% sodium chloride
- Premedicate (acetaminophen, diphenhydramine, dexamethasone) to reduce CRS/IRR
- Hospitalize for 24 hours after each of the two step-up doses
- Provide anti-infective prophylaxis (incl. PJP and herpesvirus)
Cautions
- Cytokine release syndrome (CRS)
- Neurologic toxicity, including ICANS
- Infections (serious/fatal, including opportunistic; PML reported)
- Neutropenia
- Hepatotoxicity
- Embryo-fetal toxicity
Adverse reactions
- Musculoskeletal pain
- Cytokine release syndrome
- Cough
- Upper respiratory tract infection
- Diarrhea
- Fatigue
- Pneumonia
- Nausea
- Headache
- Dyspnea
Pregnancy May cause fetal harm based on mechanism of action; no human data. Can cause B-cell lymphocytopenia in infants exposed in utero.
Lactation No data on presence in human milk; advise not to breastfeed during treatment and for 3 months after last dose.
⚠ BOXED WARNINGS
- Cytokine release syndrome
- Neurologic toxicity including ICANS
Classes and tags
Clinical profile
Mechanism of action: Linvoseltamab ballicule
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