Tecvayli (teclistamab-cqyv)
An approved treatment for Multiple Myeloma.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Teclistamab-cqyv wherever you encounter it, plus the key facts at a glance.
- Generic name
- Teclistamab-cqyv
- Brand name
- Tecvayli
- Development code
- JNJ-64007957
- Drug class
- BCMA-directed CD3 T-cell engager (bispecific antibody)
- Manufacturer
- Janssen Biotech (Johnson & Johnson)
- How it's taken
- Injection under the skin by a healthcare provider, starting with step-up doses, then weekly and later every 2 or 4 weeks
Tecvayli (teclistamab-cqyv) is a bispecific antibody injection for adults with multiple myeloma that came back or stopped responding to earlier treatment[1].
- On March 5, 2026, the FDA approved Tecvayli with Darzalex Faspro after at least 1 prior line of therapy, and gave Tecvayli used alone full approval after at least 4 prior lines[3].
- In the MajesTEC-3 trial of 587 adults, Tecvayli plus Darzalex Faspro lowered the risk of the myeloma worsening or death compared with standard daratumumab combinations (hazard ratio 0.17)[1][7].
- Tecvayli carries a boxed warning for cytokine release syndrome and nerve and brain side effects, including ICANS, and is given only through the Tecvayli and Talvey REMS program[1].
- Tecvayli is not approved for newly diagnosed myeloma, and the label notes limited data with the combination in people who have already received an anti-CD38 antibody or whose myeloma no longer responds to one[1].
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Where Teclistamab-cqyv fits
Tecvayli has 2 myeloma uses on its label[1]. With Darzalex Faspro, it is for relapsed or refractory myeloma after at least 1 prior line that included a proteasome inhibitor and an immunomodulatory agent[1]. Alone, it is for relapsed or refractory myeloma after at least 4 prior lines that included a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody[1].
How Teclistamab-cqyv works
Tecvayli 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 close together, Tecvayli switches the T cell on and directs it to destroy the myeloma cell[1]. That T-cell activation releases inflammatory signaling proteins called cytokines, which is why cytokine release syndrome is the main early side effect[1].
In the newer combination, Tecvayli is given with Darzalex Faspro (daratumumab and hyaluronidase-fihj), an antibody that targets a different myeloma protein called CD38[1].
Side effects and safety
- Cytokine release syndrome. Occurred in 64% across trials, mostly grade 1 or 2 and mostly during step-up dosing; Tecvayli is held until CRS resolves or stopped for severe cases.
- Neurologic toxicity including ICANS. Neurologic toxicity in 60% and ICANS in 6% on Tecvayli alone; the label advises no driving during and for 48 hours after the step-up schedule.
- Hepatotoxicity. Liver enzymes rose in about half of patients, and one fatal case of liver failure occurred in MajesTEC-1.
- Infections. Serious infections in 30% on Tecvayli alone and 54% on the combination; fatal infections in 4.2% and 4.6%.
- Neutropenia. Decreased neutrophils in 88%, grade 3 or 4 in 70%, and febrile neutropenia in 6%.
- Hypersensitivity and administration reactions. Injection site reactions in 37% and whole-body administration reactions in 2.5%.
- Embryo-fetal toxicity. May harm an unborn baby; effective birth control during treatment and for 5 months after the last dose.
- Hospital stay for 48 hours after step-up dose 1 and step-up dose 2
- Daily monitoring near the treatment center for 48 hours after the first treatment dose
- Blood counts before and during treatment
- Liver enzymes and bilirubin before and during treatment
- Immunoglobulin (antibody) levels, with immunoglobulin replacement to keep levels above 400mg/dL
- Signs of infection, CRS and neurologic symptoms throughout treatment
Tecvayli has a boxed warning for cytokine release syndrome (CRS), an immune reaction that can cause fever, low blood pressure and low oxygen, and for neurologic toxicity, including ICANS (immune effector cell-associated neurotoxicity syndrome)[1]. Both can be life-threatening or fatal, and in August 2025 the FDA approved adding the word fatal to the neurologic part of the warning[1][4].
Across the trials of 448 people at the recommended dose, CRS occurred in 64%, almost all grade 1 or 2, and most often during the step-up doses[1]. Neurologic toxicity occurred in 60%, with grade 3 or 4 events in 6%[1]. ICANS occurred in 6% of people on Tecvayli alone in MajesTEC-1 and in 1.1% of people on the combination in MajesTEC-3[1].
Other serious risks on the label:
- Infections: in MajesTEC-3, serious infections occurred in 54% of people on the combination and fatal infections in 4.6%[1]
- Low white blood cells: decreased neutrophils occurred in 88%, grade 3 or 4 in 70%[1]
- Liver injury, including a fatal case of liver failure in MajesTEC-1[1]
- Injection site reactions in 37%, and whole-body administration reactions in 2.5%[1]
With Tecvayli alone, the most common side effects were fever (76%), CRS (72%), muscle and bone pain (44%) and injection site reactions (37%)[1]. With the combination, low antibody levels (hypogammaglobulinemia) were reported in 84%, upper respiratory infections in 79% and cough in 53%[1]. Tecvayli may harm an unborn baby, and the label advises effective birth control during treatment and for 5 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 Teclistamab-cqyv
Tecvayli is an injection under the skin given by a healthcare professional, with the dose based on body weight[1]. Treatment starts with a step-up schedule of smaller doses to lower the risk of CRS: 0.06mg/kg, then 0.3mg/kg, then the first full treatment dose of 1.5mg/kg, usually within the first week[1].
Hospital and monitoring rules on the current label:
- A 48-hour hospital stay after step-up dose 1 and after step-up dose 2[1]
- Staying near a healthcare facility with daily monitoring for 48 hours after the first treatment dose[1]
- A steroid (dexamethasone 16mg), an antihistamine (diphenhydramine 50mg) and acetaminophen 1 to 3 hours before each step-up dose and the first treatment dose[1]
With Darzalex Faspro, Darzalex Faspro is given the day before step-up dose 1, then Tecvayli is 1.5mg/kg weekly in weeks 2 to 8, 3mg/kg every 2 weeks in weeks 9 to 24, and 3mg/kg every 4 weeks from week 25[1]. Used alone, Tecvayli is 1.5mg/kg weekly, and people with a complete response or better lasting at least 6 months may move to every 2 weeks[1]. Treatment continues until the myeloma worsens or side effects become unacceptable[1].
Tecvayli is available only through the Tecvayli and Talvey REMS, a restricted program that requires certified prescribers and treatment sites and gives each patient a wallet card[1]. The label advises no driving or operating heavy machinery during and for 48 hours after the step-up schedule[1].
Availability and cost
Only available as the brand-name product.
Help paying for Tecvayli
With private insurance, the drugmaker's copay card can lower what you pay for Tecvayli. 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. 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 commercially insured patients may pay as little as $5 per dose for Tecvayli through the J&J withMe Savings Program. Savings may apply to co-pay, co-insurance or deductible. A maximum program benefit per calendar year applies, and the program does not cover the cost of giving the treatment.
For: private insurance · source - Insurance and case manager help
A dedicated Care Navigator (an experienced cancer nurse) helps explain insurance coverage and out-of-pocket costs, points to state programs, Medicare Savings Program, Medicaid and independent foundations, and connects people to transportation services. Call 833-565-9631, Monday through Friday, 8:00 AM to 8:00 PM ET.
For: private insurance, Medicare, Medicaid, no insurance · source - Free medicine program
The Johnson & Johnson Patient Assistance Program may provide Tecvayli at no cost for up to 1 year to uninsured people who meet its eligibility and income rules. Call 833-742-0791 or see PatientAssistanceInfo.com.
For: no insurance, underinsured · source
Good to know: Tecvayli withMe is free for people 18 or older prescribed Tecvayli for an approved, on-label use. The savings program does not require sharing income information, and the offer can change or end without notice. The page does not state the dollar amount of the yearly maximum benefit. Independent foundations set their own eligibility rules.
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
MajesTEC-3 (NCT05083169) randomized 587 adults who had 1 to 3 prior lines of therapy, including lenalidomide and a proteasome inhibitor, to Tecvayli plus Darzalex Faspro or to Darzalex Faspro with dexamethasone plus pomalidomide or bortezomib[1][9]. People whose myeloma no longer responded to an anti-CD38 antibody, or who had any prior BCMA therapy, were excluded[1].
Results at a median follow-up of 34.5 months, from the label:
- Progression-free survival: median not reached with the combination versus 18.1 months, hazard ratio 0.17[1]
- Overall survival: hazard ratio 0.46, with deaths in 16% versus 33%[1]
- Overall response: 89.0% versus 75.3%, and complete response or better in 81.8% versus 32.1%[1]
- No detectable myeloma (MRD negativity) in 58.4% versus 17.1% of those tested[1]
The published MajesTEC-3 paper reported 36-month progression-free survival of 83.4% with the combination and 29.7% with the comparison treatments[7]. Serious adverse events occurred in 70.7% versus 62.4%, and deaths from adverse events in 7.1% versus 5.9%[7].
MajesTEC-1 (NCT03145181 and NCT04557098) was a single-arm study of Tecvayli alone in people who had at least 3 prior therapies[1][10]. Among 110 people in the efficacy group, 61.8% responded and 28.2% reached a complete response or better[1]. The first MajesTEC-1 results were published in 2022[8].
Development history
The FDA first approved Tecvayli on October 25, 2022, under accelerated approval for adults who had at least 4 prior lines of therapy[2][3]. A shared Tecvayli and Talvey REMS replaced the original Tecvayli REMS on August 9, 2023[3].
On August 19, 2025, the FDA approved a label change that added the word fatal to the neurologic toxicity part of the boxed warning[4].
On March 5, 2026, the FDA approved 3 changes at once[3]:
- Full (traditional) approval for Tecvayli alone after at least 4 prior lines, replacing the accelerated approval[3]
- A new use with Darzalex Faspro after at least 1 prior line that included a proteasome inhibitor and an immunomodulatory agent[3]
- REMS updates matching the new hospitalization advice, and removal of the REMS communication plan, which the FDA said had been completed[3]
The 2024 label required a 48-hour hospital stay after all doses in the step-up schedule[6]. The current label limits the hospital stay to step-up doses 1 and 2 and asks for daily monitoring near the treatment center after the first treatment dose[1]. On May 6, 2026, the FDA approved a further REMS change, shared with Talvey, that updated the dispensing authorization step to reduce paperwork for pharmacies and treatment sites, and the REMS remains in place on the current label[5][1].
Explore Multiple Myeloma trials
Other Multiple Myeloma treatments
Tecvayli is one of 4 FDA-approved bispecific T-cell engagers for myeloma; Elrexfio and Lynozyfic also target BCMA, while Talvey targets a different protein, GPRC5D[1][11][12][13]. All 4 labels carry the same type of boxed warning for CRS and neurologic toxicity and require a REMS program[1][11][12][13]. Tecvayli is currently the only one with an approved use after a single prior line, based on MajesTEC-3; the other 3 are approved after at least 4 prior lines[1][11][12][13]. No trial has compared the bispecific antibodies with each other.
Common questions about Teclistamab-cqyv
▸What is Teclistamab-cqyv (Tecvayli)?
Tecvayli (teclistamab-cqyv) is a bispecific antibody injection for adults with multiple myeloma that came back or stopped responding to earlier treatment[1]. On March 5, 2026, the FDA approved Tecvayli with Darzalex Faspro after at least 1 prior line of therapy, and gave Tecvayli used alone full approval after at least 4 prior lines[3]. In the MajesTEC-3 trial of 587 adults, Tecvayli plus Darzalex Faspro lowered the risk of the myeloma worsening or death compared with standard daratumumab combinations (hazard ratio 0.17)[1][7]. Tecvayli carries a boxed warning for cytokine release syndrome and nerve and brain side effects, including ICANS, and is given only through the Tecvayli and Talvey REMS program[1]. Tecvayli is not approved for newly diagnosed myeloma, and the label notes limited data with the combination in people who have already received an anti-CD38 antibody or whose myeloma no longer responds to one[1].
▸How does Teclistamab-cqyv work?
Tecvayli 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 close together, Tecvayli switches the T cell on and directs it to destroy the myeloma cell[1]. That T-cell activation releases inflammatory signaling proteins called cytokines, which is why cytokine release syndrome is the main early side effect[1].
In the newer combination, Tecvayli is given with Darzalex Faspro (daratumumab and hyaluronidase-fihj), an antibody that targets a different myeloma protein called CD38[1].
▸What are the side effects of Teclistamab-cqyv?
Tecvayli has a boxed warning for cytokine release syndrome (CRS), an immune reaction that can cause fever, low blood pressure and low oxygen, and for neurologic toxicity, including ICANS (immune effector cell-associated neurotoxicity syndrome)[1]. Both can be life-threatening or fatal, and in August 2025 the FDA approved adding the word fatal to the neurologic part of the warning[1][4].
Across the trials of 448 people at the recommended dose, CRS occurred in 64%, almost all grade 1 or 2, and most often during the step-up doses[1]. Neurologic toxicity occurred in 60%, with grade 3 or 4 events in 6%[1]. ICANS occurred in 6% of people on Tecvayli alone in MajesTEC-1 and in 1.1% of people on the combination in MajesTEC-3[1].
Other serious risks on the label: Infections: in MajesTEC-3, serious infections occurred in 54% of people on the combination and fatal infections in 4.6%[1] Low white blood cells: decreased neutrophils occurred in 88%, grade 3 or 4 in 70%[1] Liver injury, including a fatal case of liver failure in MajesTEC-1[1] Injection site reactions in 37%, and whole-body administration reactions in 2.5%[1]
With Tecvayli alone, the most common side effects were fever (76%), CRS (72%), muscle and bone pain (44%) and injection site reactions (37%)[1]. With the combination, low antibody levels (hypogammaglobulinemia) were reported in 84%, upper respiratory infections in 79% and cough in 53%[1]. Tecvayli may harm an unborn baby, and the label advises effective birth control during treatment and for 5 months after the last dose[1].
▸How is Teclistamab-cqyv taken?
Tecvayli is an injection under the skin given by a healthcare professional, with the dose based on body weight[1]. Treatment starts with a step-up schedule of smaller doses to lower the risk of CRS: 0.06mg/kg, then 0.3mg/kg, then the first full treatment dose of 1.5mg/kg, usually within the first week[1].
Hospital and monitoring rules on the current label:
- A 48-hour hospital stay after step-up dose 1 and after step-up dose 2[1]
- Staying near a healthcare facility with daily monitoring for 48 hours after the first treatment dose[1]
- A steroid (dexamethasone 16mg), an antihistamine (diphenhydramine 50mg) and acetaminophen 1 to 3 hours before each step-up dose and the first treatment dose[1]
With Darzalex Faspro, Darzalex Faspro is given the day before step-up dose 1, then Tecvayli is 1.5mg/kg weekly in weeks 2 to 8, 3mg/kg every 2 weeks in weeks 9 to 24, and 3mg/kg every 4 weeks from week 25[1]. Used alone, Tecvayli is 1.5mg/kg weekly, and people with a complete response or better lasting at least 6 months may move to every 2 weeks[1]. Treatment continues until the myeloma worsens or side effects become unacceptable[1].
Tecvayli is available only through the Tecvayli and Talvey REMS, a restricted program that requires certified prescribers and treatment sites and gives each patient a wallet card[1]. The label advises no driving or operating heavy machinery during and for 48 hours after the step-up schedule[1].
▸Is Teclistamab-cqyv FDA approved?
Yes, Teclistamab-cqyv (Tecvayli) is FDA approved (2022) for the treatment of Multiple Myeloma.
▸Do you have to stay in the hospital for Tecvayli?
Yes, the current Tecvayli label calls for a 48-hour hospital stay after each of the first 2 step-up doses[1].
After that: For 48 hours after the first full treatment dose, the label asks people to stay near a healthcare facility with daily monitoring[1].
What changed: The 2024 label required a 48-hour stay after all step-up doses, including the first treatment dose[6].
Driving: The label advises no driving during and for 48 hours after the step-up schedule[1].
Source: Tecvayli prescribing information (DailyMed); Tecvayli label, 2024 (FDA)
▸Can Tecvayli be used with Darzalex Faspro?
Yes, since March 5, 2026, Tecvayli is FDA approved with Darzalex Faspro for relapsed or refractory myeloma after at least 1 prior line[3].
Who: The prior treatment must have included a proteasome inhibitor and an immunomodulatory agent[1].
Trial: In MajesTEC-3, the combination had a progression-free survival hazard ratio of 0.17 against standard daratumumab combinations[1].
Limit: The label notes limited data in people who have already received an anti-CD38 antibody or whose myeloma no longer responds to one[1].
Source: FDA approval letter, BLA 761291/S-018; Tecvayli prescribing information (DailyMed)
▸What is cytokine release syndrome with Tecvayli?
Cytokine release syndrome is an immune reaction to the activated T cells that can cause fever, low blood pressure and low oxygen[1].
How often: CRS occurred in 64% of people across the trials, mostly grade 1 or 2[1].
When: Most cases came after step-up dose 1 (37%), step-up dose 2 (32%) or the first treatment dose (20%)[1].
Timing: Median onset was 2 days after the most recent dose, lasting a median of 2 days[1].
Source: Tecvayli prescribing information (DailyMed)
▸Does Tecvayli still require a REMS?
Yes, the current label says Tecvayli is available only through the Tecvayli and Talvey REMS[1].
What it means: Prescribers, pharmacies and treatment sites must be certified, and patients receive a wallet card listing CRS and neurologic warning signs[1].
Change in 2026: In March 2026 the FDA removed the communication plan from the REMS but kept the restricted program[3].
Contact: The REMS line printed on the label is 1-855-810-8064[1].
Source: Tecvayli prescribing information (DailyMed); FDA approval letter, BLA 761291/S-018
▸How much does Tecvayli cost?
A list price is not stated on the label, and Trial Friend does not publish a price it cannot confirm.
Savings: Johnson & Johnson says eligible commercially insured patients may pay as little as $5 per dose, up to a yearly maximum, and the program does not cover the cost of giving the treatment[14].
No insurance: J&J says its Patient Assistance Program may provide the medicine at no cost for up to 1 year to people who meet its rules[14].
Source: Tecvayli Savings and Support page (Johnson & Johnson)
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 (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. Food and Drug Administration · 2026-05-06. Drugs@FDA: TECVAYLI, BLA 761291, approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761291
- U.S. Food and Drug Administration · 2026-03-05. BLA 761291/S-018 supplement approval: conversion to traditional approval, combination with daratumumab and hyaluronidase-fihj, and REMS modification. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761291Orig1s018ltr.pdf
- U.S. Food and Drug Administration · 2025-08-19. BLA 761291/S-013 supplement approval: Boxed Warning and section 5.2 revised to include fatal neurologic toxicity. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761291Orig1s013ltr.pdf
- U.S. Food and Drug Administration · 2026-05-06. BLA 761291/S-017 and BLA 761342/S-019 supplement approval: Tecvayli and Talvey REMS modification. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761291Orig1s017,%20761342Orig1s019ltr.pdf
- U.S. Food and Drug Administration · 2024. TECVAYLI prescribing information, 2024 (BLA 761291/S-009). https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761291s009lbl.pdf
- New England Journal of Medicine · 2026-02-19. Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. https://doi.org/10.1056/NEJMoa2514663
- New England Journal of Medicine · 2022-08-11. Teclistamab in Relapsed or Refractory Multiple Myeloma. https://doi.org/10.1056/NEJMoa2203478
- ClinicalTrials.gov · 2026-11. A Study of Teclistamab in Combination With Daratumumab Subcutaneously (Tec-Dara) Versus DPd or DVd in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-3). https://clinicaltrials.gov/study/NCT05083169
- ClinicalTrials.gov · 2026-11. A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-1). https://clinicaltrials.gov/study/NCT04557098
- 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 (Regeneron Pharmaceuticals) · 2025-07. LYNOZYFIC (linvoseltamab-gcpt) injection, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9fd0739-1b3f-4b8b-824a-1f0a902384d3
- 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
- Johnson & Johnson · 2026-11. Savings and Support, TECVAYLI withMe. https://www.tecvayli.com/savings-support/