Lynozyfic (linvoseltamab-gcpt)
An approved treatment for Multiple Myeloma.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Linvoseltamab-gcpt wherever you encounter it, plus the key facts at a glance.
- Generic name
- Linvoseltamab-gcpt
- Brand name
- Lynozyfic
- Development code
- REGN5458
- International name
- Lynozyfic (linvoseltamab, European Union)
- Drug class
- BCMA-directed CD3 T-cell engager (bispecific antibody)
- Manufacturer
- Regeneron Pharmaceuticals
- How it's taken
- Intravenous infusion by a healthcare provider, starting with step-up doses, then weekly, every 2 weeks and possibly every 4 weeks
Lynozyfic (linvoseltamab-gcpt) is a bispecific antibody infusion for adults whose multiple myeloma came back or stopped responding after at least 4 prior lines of therapy[1].
- The FDA granted Lynozyfic accelerated approval on July 2, 2025, based on response rate and how long responses lasted, and continued approval depends on a confirmatory trial[1][2].
- In the LINKER-MM1 trial, 70% of 80 heavily pretreated adults responded and 45% reached a complete response or better[1].
- Lynozyfic carries a boxed warning for cytokine release syndrome and neurologic toxicity, including ICANS, and is given only through the Lynozyfic REMS program[1].
- Lynozyfic is not approved for earlier lines of myeloma treatment or in combination with other myeloma medicines[1].
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Where Linvoseltamab-gcpt fits
Lynozyfic has 1 myeloma use on its label[1]. It is given alone for relapsed or refractory myeloma after at least 4 prior lines of therapy that included a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody[1]. The label's main study did not include people who had already received a BCMA bispecific antibody or BCMA CAR T-cell therapy[1].
How Linvoseltamab-gcpt works
Lynozyfic is a bispecific antibody, a lab-made protein with 2 different arms[1]. One arm grabs BCMA (B-cell maturation antigen), a protein on the surface of myeloma cells and some healthy B-lineage cells[1]. The other arm grabs CD3, part of the switch that turns on T cells, the immune cells that kill infected or abnormal cells[1].
By holding a T cell and a myeloma cell together, Lynozyfic switches the T cell on so it can destroy the myeloma cell[1][3]. That activation releases inflammatory signaling proteins called cytokines, which rose mostly during the step-up doses and the first full 200mg dose, according to the label[1]. This is why cytokine release syndrome is the main early side effect[1].
Lynozyfic is a ready-to-use medicine, so Regeneron says there is no wait for personalized manufacturing once a doctor decides to start it[4].
Side effects and safety
- Cytokine release syndrome. Occurred in 46% in LINKER-MM1, mostly grade 1 or 2 and mostly after step-up dose 1; Lynozyfic is held until CRS resolves or stopped based on severity.
- Neurologic toxicity including ICANS. Neurologic toxicity in 54% (grade 3 or 4 in 8%) and ICANS in 8%; no driving for 48 hours after each step-up dose.
- Infections. Serious infections in 42% and fatal infections in 4%, including 2 cases of PML; the label calls for preventive medicines and immunoglobulin monitoring.
- Neutropenia. Decreased neutrophils in 62%, grade 3 or 4 in 47%, and febrile neutropenia in 8%.
- Hepatotoxicity. Raised AST in 61% (grade 3 or 4 in 10%) and raised ALT in 46% (grade 3 or 4 in 6%).
- Embryo-fetal toxicity. May harm an unborn baby; effective birth control during treatment and for 3 months after the last dose.
- Hospital stay for 24 hours after step-up dose 1 and step-up dose 2
- Signs of CRS and neurologic symptoms after each infusion and throughout treatment
- Complete blood counts at baseline and periodically
- Liver enzymes and bilirubin at baseline and during treatment
- Immunoglobulin levels and signs of infection before and during treatment
- Pregnancy test before starting treatment
Lynozyfic has a boxed warning for cytokine release syndrome (CRS), an immune reaction that can cause fever, chills, low oxygen, a fast heartbeat and low blood pressure, and for neurologic toxicity, including ICANS (immune effector cell-associated neurotoxicity syndrome)[1]. Both can be serious or life-threatening[1].
In LINKER-MM1, among 117 people given the recommended dose[1]:
- CRS occurred in 46%, mostly grade 1 (35%) or grade 2 (10%), with 1 grade 3 case (0.9%)[1]
- Most CRS came after step-up dose 1 (38%), and median onset was 11 hours after the end of the infusion[1]
- Neurologic toxicity occurred in 54%, grade 3 or 4 in 8%, and ICANS in 8%[1]
- Infusion-related reactions occurred in 9%[1]
Other serious risks on the label:
Serious adverse reactions occurred in 74% of people, and fatal adverse reactions in 7%, most often sepsis (3.4%)[1]. The most common side effects were muscle and bone pain, CRS, cough, upper respiratory infections, diarrhea, tiredness, pneumonia, nausea, headache and shortness of breath[1]. Lynozyfic may harm an unborn baby, and the label advises effective birth control during treatment and for 3 months after the last dose[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Linvoseltamab-gcpt
Lynozyfic is an intravenous infusion given by a healthcare provider with emergency equipment close by[1]. Treatment starts with a step-up schedule of smaller doses to lower the risk of CRS[1]:
After that, the label lists 200mg one week later, then weekly from week 4 to week 13 for 10 doses, then every 2 weeks from week 14[1]. People who reach a very good partial response or better at or after week 24, and have had at least 17 full doses, move to every 4 weeks[1]. Later infusions take 1 hour for the second full dose and 30 minutes after that, if there is no CRS[1].
Hospital and premedication rules on the label:
- A 24-hour hospital stay after step-up dose 1 and after step-up dose 2[1]
- Acetaminophen, diphenhydramine and dexamethasone before each step-up dose and the first 2 full doses, with dexamethasone 40mg before the step-up doses and the first full dose[1]
- No driving or operating heavy machinery for 48 hours after each step-up dose[1]
Lynozyfic is available only through the Lynozyfic REMS, which requires certified prescribers, pharmacies and treatment sites, and gives each patient a wallet card listing CRS and neurologic warning signs[1]. Treatment continues until the myeloma worsens or side effects become unacceptable[1].
Availability and cost
Only available as the brand-name product.
Help paying for Lynozyfic
With private insurance, the drugmaker's copay card can lower what you pay for Lynozyfic. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE, but charity funds often can. Of the 5 charity funds for Multiple Myeloma, 1 was open on October 26, 2026. People on Medicare may still qualify for the drugmaker's free medicine program. Without insurance, you can apply to the drugmaker's free medicine program, which sets its own eligibility rules. Pick your insurance below to see which offers fit you.
- Copay help
Eligible patients with private (commercial) insurance may pay as little as $0 out of pocket through the Lynozyfic Surround Commercial Copay Program, with up to $25,000 in assistance per year toward copays, coinsurance and deductibles for the drug and its administration. There is no income requirement. Not valid for Medicare, Medicaid, VA/DoD, TRICARE or similar programs, and it does not cover supplies. Residents of Massachusetts or Rhode Island are not eligible for administration assistance.
For: private insurance · source - Free medicine program
People who are uninsured, underinsured or lack coverage for Lynozyfic, or who have Medicare and cannot afford their out-of-pocket costs, may receive Lynozyfic at no cost through the Lynozyfic Surround Patient Assistance Program if they meet household income criteria and are treated as outpatients by a licensed US provider. Enrollment lasts up to 12 months (Medicare patients until the end of the calendar year), and patients must reapply each year.
For: no insurance, underinsured, Medicare · source - Insurance and case manager help
Patient Navigators can point to independent transportation and lodging resources, local support groups and other help, and send appointment reminders. Lynozyfic Surround can also check eligibility for assistance and identify independent third-party financial resources. Call 1-844-746-4363 (1-844-RGN-HEME), Option 1, Monday through Friday, 8 AM to 8 PM ET.
For: private insurance, Medicare, Medicaid, no insurance · source
Good to know: Lynozyfic Surround is Regeneron's program for adults in the US and its territories prescribed Lynozyfic for its FDA-approved use. Regeneron says it can rescind, end or change the copay offer at any time without notice. Details come from Regeneron's patient treatment guide (07/25); the program web page could not be read as text on November 4, 2026.
Charity funds for Multiple Myeloma
- From a charity · HealthWell FoundationMultiple Myeloma (Medicare Access) fundOpen
Pays for: Copays, premiums or other treatment costs. Medicare patients only.
Clinical trial results
LINKER-MM1 (NCT03761108) is an open-label phase 1/2 study of Lynozyfic alone in relapsed or refractory myeloma[1][6]. The study excluded people who had any prior BCMA-directed bispecific antibody, any prior bispecific T-cell engager, or prior BCMA CAR T-cell therapy[1].
The efficacy group on the label was 80 people who had at least 4 prior lines of therapy, with a median of 5[1]. Among them, 79% were triple-class refractory and 13% had received a BCMA antibody-drug conjugate before[1].
Results from the label:
The LINKER-MM1 phase 2 results were published in the Journal of Clinical Oncology in 2024[5]. The confirmatory phase 3 trial, LINKER-MM3 (NCT05730036), compares Lynozyfic with elotuzumab, pomalidomide and dexamethasone, and ClinicalTrials.gov listed it as recruiting in November 2026[7][3].
Development history
The FDA granted Lynozyfic accelerated approval on July 2, 2025, for adults with relapsed or refractory myeloma after at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody[2][3]. Accelerated approval means the FDA relied on response rate and durability of response, and continued approval may depend on a confirmatory trial[1].
Regeneron said in its approval announcement that Lynozyfic was also approved in the European Union, after at least 3 prior therapies[3].
Drugs@FDA lists a REMS modification approved on July 31, 2026, and the current label still requires the Lynozyfic REMS[2][1]. The prescribing information on DailyMed was last revised in July 2025, and no myeloma indication has been added or withdrawn since approval[1][2].
Explore Multiple Myeloma trials
Other Multiple Myeloma treatments
Lynozyfic is one of 4 FDA-approved bispecific T-cell engagers for myeloma; Tecvayli and Elrexfio also target BCMA, while Talvey targets a different protein, GPRC5D[1][8][9][10]. All 4 labels carry the same type of boxed warning for CRS and neurologic toxicity and require a REMS program[1][8][9][10]. Lynozyfic is given as an infusion into a vein, while the other 3 are injected under the skin[1][8][9][10]. No trial has compared the bispecific antibodies with each other.
Common questions about Linvoseltamab-gcpt
▸What is Linvoseltamab-gcpt (Lynozyfic)?
Lynozyfic (linvoseltamab-gcpt) is a bispecific antibody infusion for adults whose multiple myeloma came back or stopped responding after at least 4 prior lines of therapy[1]. The FDA granted Lynozyfic accelerated approval on July 2, 2025, based on response rate and how long responses lasted, and continued approval depends on a confirmatory trial[1][2]. In the LINKER-MM1 trial, 70% of 80 heavily pretreated adults responded and 45% reached a complete response or better[1]. Lynozyfic carries a boxed warning for cytokine release syndrome and neurologic toxicity, including ICANS, and is given only through the Lynozyfic REMS program[1]. Lynozyfic is not approved for earlier lines of myeloma treatment or in combination with other myeloma medicines[1].
▸How does Linvoseltamab-gcpt work?
Lynozyfic is a bispecific antibody, a lab-made protein with 2 different arms[1]. One arm grabs BCMA (B-cell maturation antigen), a protein on the surface of myeloma cells and some healthy B-lineage cells[1]. The other arm grabs CD3, part of the switch that turns on T cells, the immune cells that kill infected or abnormal cells[1].
By holding a T cell and a myeloma cell together, Lynozyfic switches the T cell on so it can destroy the myeloma cell[1][3]. That activation releases inflammatory signaling proteins called cytokines, which rose mostly during the step-up doses and the first full 200mg dose, according to the label[1]. This is why cytokine release syndrome is the main early side effect[1].
Lynozyfic is a ready-to-use medicine, so Regeneron says there is no wait for personalized manufacturing once a doctor decides to start it[4].
▸What are the side effects of Linvoseltamab-gcpt?
Lynozyfic has a boxed warning for cytokine release syndrome (CRS), an immune reaction that can cause fever, chills, low oxygen, a fast heartbeat and low blood pressure, and for neurologic toxicity, including ICANS (immune effector cell-associated neurotoxicity syndrome)[1]. Both can be serious or life-threatening[1].
In LINKER-MM1, among 117 people given the recommended dose[1]: CRS occurred in 46%, mostly grade 1 (35%) or grade 2 (10%), with 1 grade 3 case (0.9%)[1] Most CRS came after step-up dose 1 (38%), and median onset was 11 hours after the end of the infusion[1] Neurologic toxicity occurred in 54%, grade 3 or 4 in 8%, and ICANS in 8%[1] Infusion-related reactions occurred in 9%[1]
Other serious risks on the label: Infections: serious infections in 42% and fatal infections in 4%, with 2 cases of PML, a rare brain infection[1] Low neutrophils in 62%, grade 3 or 4 in 47%, and febrile neutropenia in 8%[1] Liver injury: raised AST in 61% and raised ALT in 46%, which can happen with or without CRS[1]
Serious adverse reactions occurred in 74% of people, and fatal adverse reactions in 7%, most often sepsis (3.4%)[1]. The most common side effects were muscle and bone pain, CRS, cough, upper respiratory infections, diarrhea, tiredness, pneumonia, nausea, headache and shortness of breath[1]. Lynozyfic may harm an unborn baby, and the label advises effective birth control during treatment and for 3 months after the last dose[1].
▸How is Linvoseltamab-gcpt taken?
Lynozyfic is an intravenous infusion given by a healthcare provider with emergency equipment close by[1]. Treatment starts with a step-up schedule of smaller doses to lower the risk of CRS[1]:
- Day 1: step-up dose 1 of 5mg, given over 4 hours[1]
- Day 8: step-up dose 2 of 25mg, given over 4 hours[1]
- Day 15: the first full treatment dose of 200mg, given over 4 hours[1]
After that, the label lists 200mg one week later, then weekly from week 4 to week 13 for 10 doses, then every 2 weeks from week 14[1]. People who reach a very good partial response or better at or after week 24, and have had at least 17 full doses, move to every 4 weeks[1]. Later infusions take 1 hour for the second full dose and 30 minutes after that, if there is no CRS[1].
Hospital and premedication rules on the label:
- A 24-hour hospital stay after step-up dose 1 and after step-up dose 2[1]
- Acetaminophen, diphenhydramine and dexamethasone before each step-up dose and the first 2 full doses, with dexamethasone 40mg before the step-up doses and the first full dose[1]
- No driving or operating heavy machinery for 48 hours after each step-up dose[1]
Lynozyfic is available only through the Lynozyfic REMS, which requires certified prescribers, pharmacies and treatment sites, and gives each patient a wallet card listing CRS and neurologic warning signs[1]. Treatment continues until the myeloma worsens or side effects become unacceptable[1].
▸Is Linvoseltamab-gcpt FDA approved?
Yes, Linvoseltamab-gcpt (Lynozyfic) is FDA approved (2025) for the treatment of Multiple Myeloma.
▸Do you have to stay in the hospital for Lynozyfic?
Yes, the Lynozyfic label calls for a 24-hour hospital stay after each of the first 2 step-up doses[1].
Why: These are the doses when CRS and neurologic side effects are most likely[1].
Driving: The label advises no driving for 48 hours after each step-up dose[1].
Later doses: The label does not set a hospital stay after the full treatment doses, but calls for prompt evaluation at the first sign of CRS[1].
Source: Lynozyfic prescribing information (DailyMed)
▸How often is Lynozyfic given?
After 3 weekly starting doses, Lynozyfic is given weekly, then every 2 weeks from week 14[1].
Every 4 weeks: People with a very good partial response or better at or after week 24, and at least 17 full doses, move to every 4 weeks[1].
Dose: Each full dose is 200mg[1].
Infusion time: 4 hours at first, then 1 hour, then 30 minutes if there is no CRS[1].
Source: Lynozyfic prescribing information (DailyMed)
▸How well does Lynozyfic work?
In LINKER-MM1, 70% of 80 people who had at least 4 prior lines of therapy responded to Lynozyfic[1].
Depth: 45% reached a complete response or better[1].
Speed: Median time to first response was 0.95 months[1].
Duration: An estimated 72% of responders were still responding at 12 months[1].
Limit: The approval is accelerated, so a confirmatory trial is still required[1].
Source: Lynozyfic prescribing information (DailyMed)
▸What is cytokine release syndrome with Lynozyfic?
Cytokine release syndrome is an immune reaction to the activated T cells that can cause fever, chills, low oxygen, a fast heartbeat and low blood pressure[1].
How often: CRS occurred in 46% of people in LINKER-MM1, with 1 grade 3 case[1].
When: Most cases followed step-up dose 1 (38%), and 17% had CRS after step-up dose 2[1].
Timing: Median onset was 11 hours after the infusion ended, lasting a median of 15 hours[1].
Source: Lynozyfic prescribing information (DailyMed)
▸How much does Lynozyfic cost?
A list price is not stated on the label, and Trial Friend does not publish a price it cannot confirm.
Commercial insurance: Regeneron says eligible patients may pay as little as $0, with up to $25,000 in assistance per year for the drug and its administration[4].
Other coverage: Regeneron says people who are uninsured, underinsured or on Medicare and cannot afford their costs may get Lynozyfic at no cost if they meet income rules[4].
Source: Your Lynozyfic Treatment Guide (Regeneron)
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed (Regeneron Pharmaceuticals) · 2025-07. LYNOZYFIC (linvoseltamab-gcpt) injection, for intravenous use, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9fd0739-1b3f-4b8b-824a-1f0a902384d3
- U.S. Food and Drug Administration · 2026-07-31. Drugs@FDA: LYNOZYFIC, BLA 761400, approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761400
- Regeneron Pharmaceuticals · 2025-07-02. Lynozyfic (linvoseltamab-gcpt) Receives FDA Accelerated Approval for Treatment of Relapsed or Refractory Multiple Myeloma. https://investor.regeneron.com/news-releases/news-release-details/lynozyfictm-linvoseltamab-gcpt-receives-fda-accelerated-approval
- Regeneron Pharmaceuticals · 2025-07. Your LYNOZYFIC Treatment Guide. https://www.lynozyfichcp.com/sfsites/c/cms/delivery/media/MCIQZ4XIAFINEL7DXVRIBTGGJWXA
- Journal of Clinical Oncology · 2024-08-01. Linvoseltamab for Treatment of Relapsed/Refractory Multiple Myeloma. https://doi.org/10.1200/JCO.24.01008
- ClinicalTrials.gov · 2026-11. Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma (LINKER-MM1). https://clinicaltrials.gov/study/NCT03761108
- ClinicalTrials.gov · 2026-11. A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma (LINKER-MM3). https://clinicaltrials.gov/study/NCT05730036
- U.S. National Library of Medicine, DailyMed (Janssen Biotech, Inc.) · 2026-04. TECVAYLI (teclistamab-cqyv) injection, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54e0f974-ccee-44ea-9254-40e9883cee1e
- U.S. National Library of Medicine, DailyMed (Pfizer) · 2026-05. ELREXFIO (elranatamab-bcmm) injection, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aa044060-5b4b-4692-bf0f-9a50e140b10e
- U.S. National Library of Medicine, DailyMed (Janssen Biotech, Inc.) · 2025-11. TALVEY (talquetamab-tgvs) injection, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9001355e-003d-4d4e-b4ce-337e0fd14952