Brand Name
Lynozyfic
Generic Name
Linvoseltamab-Gcpt
View Brand Information FDA approval date: July 02, 2025
Form: Injection
What is Lynozyfic (Linvoseltamab-Gcpt)?
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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial. LYNOZYFIC is a bispecific B-cell maturation antigen ‑directed CD3 T-cell engager 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial.
Approved To Treat
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Brand Information
LYNOZYFIC (linvoseltamab-gcpt)
WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITY, INCLUDING IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME
- Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LYNOZYFIC. Initiate treatment with LYNOZYFIC step-up dosing to reduce the risk of CRS. Manage CRS, withhold LYNOZYFIC until CRS resolves, and modify the next dose or permanently discontinue based on severity
- Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), including serious or life-threatening reactions, can occur in patients receiving LYNOZYFIC. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS during treatment. Manage neurologic toxicity, including ICANS, withhold LYNOZYFIC until neurologic toxicity, including ICANS resolves, and modify the next dose or permanently discontinue based on severity
- Because of the risk of CRS and neurologic toxicity, including ICANS, LYNOZYFIC is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the LYNOZYFIC REMS
1INDICATIONS AND USAGE
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
2DOSAGE FORMS AND STRENGTHS
LYNOZYFIC is a clear to slightly opalescent, colorless to pale yellow solution, available as:
- Injection: 5 mg/2.5 mL (2 mg/mL) single-dose vial
- Injection: 200 mg/10 mL (20 mg/mL) single-dose vial
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Cytokine Release Syndrome
- Neurologic Toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome
- Infections
- Neutropenia
- Hepatotoxicity
4.1Clinical 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.
5DESCRIPTION
Linvoseltamab-gcpt, a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, is a recombinant human immunoglobulin (Ig)G4 antibody. Linvoseltamab-gcpt is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. The molecular weight of linvoseltamab-gcpt is approximately 146 kDa.
LYNOZYFIC (linvoseltamab-gcpt) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution with a pH 6.0.
Each LYNOZYFIC 5 mg/2.5 mL vial contains 5 mg of linvoseltamab-gcpt. Each mL contains 2 mg of linvoseltamab-gcpt, histidine (0.7 mg), L-histidine hydrochloride monohydrate (1.1 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP.
Each LYNOZYFIC 200 mg/10 mL vial contains 200 mg of linvoseltamab-gcpt. Each mL contains 20 mg of linvoseltamab-gcpt, histidine (0.7 mg), L-histidine hydrochloride monohydrate (1.1 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP.
6HOW SUPPLIED/STORAGE AND HANDLING
LYNOZYFIC (linvoseltamab-gcpt) injection is a clear to slightly opalescent, colorless to pale yellow solution in a single-dose vial. It is supplied as provided in Table 11.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
8PRINCIPAL DISPLAY PANEL - 5 mg / 2.5 mL Vial Carton
NDC 61755-054-01
LYNOZYFIC™
5 mg / 2.5 mL (2 mg/mL)
For Intravenous Infusion after Dilution
Single-Dose Vial. Discard unused portion.
ATTENTION: Dispense the enclosed Medication Guide
One 2.5 mL Vial
9PRINCIPAL DISPLAY PANEL - 200 mg / 10 mL Vial Carton
NDC 61755-056-01
LYNOZYFIC™
200 mg / 10 mL (20 mg/mL)
For Intravenous Infusion after Dilution
Single-Dose Vial. Discard unused portion.
ATTENTION: Dispense the enclosed Medication Guide
One 10 mL Vial
