Lynozyfic

Adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a PI, IMiD, and anti-CD38 antibody.

Step-up dosing: 0.1 mg/kg Day 1, 0.3 mg/kg Day 8, then 200 mg Q2W starting Day 15. Hospitalize for first two step-up doses.

Injection: 100 mg/mL single-dose vial

None listed in the prescribing information.

• CRS: Occurred in 45% of patients. Premedicate and monitor closely.
• ICANS: Monitor for neuropsychiatric signs.
• Infections: Serious and fatal infections including opportunistic infections.
• Cytopenias: Prolonged neutropenia and thrombocytopenia. Monitor CBCs.

CRS (45%), Fatigue (38%), Infections (36%), Neutropenia (34%), Anemia (30%), Diarrhea (26%), Injection Site Reactions (22%), Musculoskeletal Pain (20%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Live Vaccines: Avoid during and after treatment.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Linvoseltamab is a bispecific antibody that simultaneously binds BCMA on myeloma cells and CD3 on T cells, redirecting T cells to kill BCMA-expressing myeloma cells.

Half-life: ~12 days at steady state. Nonlinear PK with target-mediated clearance.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• LINKER-MM1 — Linvoseltamab in R/R multiple myeloma. Phase I/II, n=117.
  🔬 NCT03761108 ↗

Lynozyfic has FDA-approved indications across the following cancer types covered on CancerDrugEvidence: