Lynozyfic

Pronunciation: Lin-oh-zye-fic
Generic name: linvoseltamab
Dosage form: injection for intravenous use in a single-dose vial (5 mg/2.5 mL, 200 mg/10 mL)

Medically reviewed by Carmen Pope, BPharm. Last updated on Jul 3, 2025.

What is Lynozyfic?

Lynozyfic is used to treat relapsed or refractory multiple myeloma in adults who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody. It is administered as an intravenous infusion, once a week or once every 2 weeks.

Lynozyfic works by acting as a bridge between T-cells and multiple myeloma (MM) cells, attaching to specific proteins (CD3 on T-cells and the BCMA protein on MM cells and some normal B-cells). This connection activates T-cells to attack and destroy the cancer cells. Lynozyfic belongs to the drug class called bispecific B-cell maturation antigen (BCMA)‑directed CD3 T-cell engagers.

Lynozyfic (linvoseltamab) gained accelerated FDA approval on July 2, 2025. Approval was based on response rate and durability of response from the phase I/II LINKER-MM1 clinical trial (NCT03761108), where linvoseltamab achieved a 71% overall response rate at a 200 mg dose in heavily pretreated r/r Multiple Myeloma patients.

• At 14-month follow-up, 50% achieved complete response or better, with a median duration of response of 29.4 months.
• Continued approval may be contingent on a clinical benefit in confirmatory trials.

Side effects

The most common side effects of Lynozyfic are:

• musculoskeletal pain
• cytokine release syndrome
• cough
• upper respiratory tract infection
• diarrhea
• fatigue
• pneumonia
• nausea
• headache
• shortness of breath (dyspnea).

Serious side effects and warnings

Lynozyfic carries a Boxed Warning for cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome.

Cytokine Release Syndrome (CRS). This is a potentially life-threatening condition where the immune system overreacts and releases excessive amounts of cytokines, leading to widespread inflammation and organ dysfunction. Step-up dosing of Lynozyfic can reduce the risk of CRS. Tell your healthcare provider immediately if you develop symptoms such as fever, low blood pressure, trouble breathing, or vomiting.

Neurologic toxicity. In the LINKER-MM1 clinical trial, neurologic toxicity occurred in 54% of patients receiving Lynozyfic, with Grade 3 or 4 neurologic toxicity occurring in 8%. Neurologic toxicities included immune effector cell-associated neurotoxicity syndrome (ICANS), lower levels of consciousness, confusion, memory loss, and coma. Tell your healthcare provider immediately if you experience any of these symptoms.

Lynozyfic may also cause other serious side effects such as:

• Infections: Can cause serious or fatal infections. Tell your healthcare provider immediately if you experience any signs or symptoms of an infection, such as fever, chills, weakness, shortness of breath, or urinary changes.
• Neutropenia (low numbers of neutrophils, a white blood cell). Your healthcare provider will monitor your blood cell counts at baseline and periodically during treatment.
• Liver toxicity. Lynozyfic may affect your liver. Your healthcare provider will monitor your liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Tell your healthcare provider immediately if you develop fatigue, weight loss, right upper abdominal discomfort, dark urine, or jaundice [ abdominal pain, fatigue, yellowing of the skin or eyes.
• Harm to an unborn baby. Lynozyfic may harm an unborn baby. Females of childbearing potential should use effective contraception during treatment with Lynozyfic and for 3 months after the last dose.

These are not all the side effects of Lynozyfic. To report suspected side effects, contact Regeneron at 1-844-467-2998 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Related/similar drugs

Lynozyfic REMS

Lynozyfic is available only through a restricted program under a REMS called the Lynozyfic REMS because of the risks of CRS and neurologic toxicity, including ICANS.

• You will be provided with a Lynozyfic Patient Wallet Card which you should show to all your healthcare providers.
• Pharmacies and healthcare settings that dispense Lynozyfic must be certified with the Lynozyfic REMS program and must verify prescribers are certified through the Lynozyfic REMS program.

Further information about the Lynozyfic REMS program is available at lynozyficREMS.com or by telephone at 1-855-212-6391.

Before receiving

Before receiving Lynozyfic, tell your healthcare provider about all your medical problems, including if you have or have had:

• neurologic problems (such as seizures, stroke, or memory loss)
• lung or breathing problems
• liver problems
• a recent or active infection
• are pregnant or intend to become pregnant
• are breastfeeding.

Pregnancy

If you are a woman of childbearing potential, your healthcare provider may conduct pregnancy testing before receiving this medicine. You will also need to use birth control to prevent pregnancy during and for 3 months after treatment with Lynozyfic.

Tell your healthcare provider right away if you become pregnant or are pregnant.  

Breastfeeding

Do not breastfeed while using this medicine and for 3 months after the last dose.

How do I receive Lynozyfic?

Lynozyfic is given as an intravenous infusion according to the step-up dosing schedule to reduce the risk and severity of CRS.

• For the first 3 step-up doses, Lynozyfic should be infused over 4 hours.
• The second treatment dose can be infused over 1 hour.
• Subsequent doses can be infused over 30 minutes.
• You should be hospitalized for 24 hours after administration of the first step-up dose and for 24 hours after administration of the second step-up dose.

Your healthcare provider will give you the following pretreatment medications before each dose of the step-up dosing schedule and subsequent doses thereafter:

• Acetaminophen (or equivalent): 650 mg to 1000 mg orally, 30 to 60 minutes before the infusion
• Diphenhydramine (or equivalent): 25 mg orally or intravenously, 30 to 60 minutes before the infusion
• Dexamethasone (or equivalent) intravenously 1 to 3 hours before infusion.
  • 40 mg dexamethasone (or equivalent) before step-up dose 1, step-up dose 2, and the first full treatment dose.
  • Once a treatment dose of Lynozyfic is tolerated without CRS and/or IRR with 40 mg dexamethasone (or equivalent), administer 10 mg dexamethasone (or equivalent) before the subsequent Lynozyfic treatment dose.

Pre-treatment medications may be discontinued once a treatment dose of Lynozyfic is tolerated without CRS and/or IRR following pre-treatment medications.

Dosing information

Dose of Lynozyfic for r/r Multiple Myeloma (adults)

• Day 1 (step-up dose 1): 5 mg
• Day 8 (step-up dose 2): 25 mg
• Day 15 (first-treatment dose): 200 mg
• One week after Day 15 (second treatment dose): 200 mg
• Once weekly from Week 4 to Week 13 for 10 treatment doses: 200 mg
• Week 14 and every 2 weeks thereafter: 200 mg every 2 weeks.

For patients who have achieved and maintained VGPR or better at or after Week 24 and received at least 17 doses of 200 mg

• Week 24 and every 4 weeks thereafter: 200 mg every 4 weeks.

What do I avoid while receiving Lynozyfic?

Avoid driving or operating heavy or potentially dangerous machinery for 48 hours after completing each of the step-up doses, and if you experience any neurological symptoms, until symptoms resolve.

Ingredients

Active ingredients: linvoseltamab-gcpt

Inactive ingredients: histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, and Water for Injection, USP.

Lynozyfic injection is available as:

• 5 mg/2.5 mL (2 mg/mL) single-dose vial
• 200 mg/10 mL (20 mg/mL) single-dose vial.

Manufacturer

Lynozyfic (linvoseltamab-gcpt) is manufactured by Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591-6707.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer