Talvey (talquetamab-tgvs)
An approved treatment for Multiple Myeloma.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Talquetamab-tgvs wherever you encounter it, plus the key facts at a glance.
- Generic name
- Talquetamab-tgvs
- Brand name
- Talvey
- Development code
- JNJ-64407564
- Drug class
- GPRC5D-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 or every 2 weeks
Talvey (talquetamab-tgvs) is a bispecific antibody injection that targets GPRC5D, for adults whose multiple myeloma came back or stopped responding after at least 4 prior lines of therapy[1].
- The FDA granted Talvey accelerated approval on August 9, 2023, based on response rates, so continued approval may depend on a confirmatory trial[2][1].
- In MonumenTAL-1, 73% of 100 people on the weekly dose and 73.6% of 87 people on the every-2-week dose responded[1].
- Talvey carries a boxed warning for cytokine release syndrome and neurologic toxicity, including ICANS, and is given only through the Tecvayli and Talvey REMS program[1].
- Talvey is not approved for earlier lines of therapy, although the MonumenTAL-3 trial of Talvey with daratumumab was published in 2026[1][6].
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Where Talquetamab-tgvs fits
Talvey is approved 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[1]. It is used on its own, and the label includes results in people who had already received CAR T or bispecific therapy[1].
How Talquetamab-tgvs works
Talvey is a bispecific antibody with 2 different binding arms[1]. One arm binds GPRC5D (G protein-coupled receptor class C group 5 member D), a protein on myeloma cells and normal plasma cells[1]. The other arm binds CD3 on T cells, the immune cells that kill abnormal cells[1].
By bridging the 2 cells, Talvey switches the T cell on, which releases inflammatory cytokines and destroys the myeloma cell[1]. GPRC5D is a different target from BCMA, the protein used by Tecvayli, Elrexfio and Lynozyfic[1][9].
GPRC5D is also found in healthy keratinized tissue of the skin and tongue, according to the label[1]. Taste changes, mouth problems, skin peeling and nail changes are common side effects of Talvey[1].
Side effects and safety
- Cytokine release syndrome. Occurred in 76%, mostly grade 1 or 2, most often after step-up doses; recurrent CRS in 30%.
- Neurologic toxicity including ICANS. Neurologic toxicity in 55% and ICANS in 9%; ataxia was added to the label in October 2025.
- Oral toxicity and weight loss. Mouth problems in 80% and weight loss in 62%; weight is checked regularly and a nutritionist may help.
- Infections. Serious infections in 16% and fatal infections in 1.5%.
- Cytopenias. Grade 3 or 4 low neutrophils in 35% and low platelets in 22%.
- Skin toxicity. Skin reactions in 62%, including rash and peeling, rarely grade 3.
- Hepatotoxicity. Raised ALT in 33% and AST in 31%, with or without CRS.
- Embryo-fetal toxicity. May harm an unborn baby; effective birth control during treatment and for 3 months after the last dose.
- Hospital stay for 48 hours after every dose in the step-up schedule, including the first full treatment dose
- Blood counts during treatment
- Weight and mouth symptoms throughout treatment
- Skin changes, including rash progression
- Liver enzymes and bilirubin at the start and during treatment
- Signs of infection, CRS and neurologic symptoms
Talvey 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]. In the clinical trial, CRS occurred in 76% of people at the recommended doses, mostly grade 1 or 2[1].
Neurologic toxicity occurred in 55%, with grade 3 or 4 events in 6%, and ICANS in 9%[1]. In October 2025 the label added ataxia, a loss of balance and coordination, to the list of neurologic toxicities[3].
Side effects tied to GPRC5D, from the label:
- Mouth problems in 80%, most often altered taste (49%), dry mouth (34%), trouble swallowing (23%) and loss of taste (18%), and they had not returned to normal in 65% at the time of analysis[1]
- Weight loss in 62%, with a loss of 10% or more of body weight in 29%[1]
- Skin reactions in 62%, and nail disorders in 50%[1]
Other serious risks include infections (serious in 16%, fatal in 1.5%), low neutrophils (grade 3 or 4 in 35%), low platelets (grade 3 or 4 in 22%) and liver injury[1]. Talvey 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 Talquetamab-tgvs
Talvey is an injection under the skin given by a qualified healthcare professional, with the dose based on actual body weight[1]. The label offers 2 schedules, each starting with step-up doses to lower the risk of CRS[1].
The 2 schedules:
The label calls for a 48-hour hospital stay after every dose in the step-up schedule, which the Medication Guide says includes the first full treatment dose[1]. A steroid (dexamethasone 16mg), an antihistamine (diphenhydramine 50mg) and acetaminophen are given 1 to 3 hours before each dose in the step-up schedule[1]. Treatment continues until the myeloma worsens or side effects become unacceptable[1].
Talvey is available only through the Tecvayli and Talvey REMS, which requires certified prescribers and treatment sites and gives each patient a wallet card[1]. The label advises no driving during the step-up schedule and for 48 hours after it ends[1].
Availability and cost
Only available as the brand-name product.
Help paying for Talvey
With private insurance, the drugmaker's copay card can lower what you pay for Talvey. 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 Talvey 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 Talvey 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: Talvey withMe is free for people 18 or older prescribed Talvey 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
MonumenTAL-1 (NCT03399799 and NCT04634552) was a single-arm, open-label study of Talvey alone in people who had at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody[1][7]. The label's efficacy results cover 187 people with at least 4 prior lines and no prior T-cell redirecting therapy[1].
Results from the label:
- Weekly 0.4mg/kg (100 people): 73% responded, with a median duration of response of 9.5 months[1]
- Every-2-week 0.8mg/kg (87 people): 73.6% responded, and an estimated 85% of responders were still responding at 9 months[1]
- After prior CAR T or bispecific therapy (32 people on the weekly dose): 72% responded[1]
The first MonumenTAL-1 results were published in 2022[5].
MonumenTAL-3 (NCT05455320) randomized 864 people with at least 1 prior line to Talvey plus daratumumab and pomalidomide, Talvey plus daratumumab, or daratumumab, pomalidomide and dexamethasone[6][8]. At an interim analysis published in 2026, the hazard ratios for progression or death against the standard combination were 0.28 and 0.33 for the 2 Talvey combinations[6]. These results are not part of the current US label[1].
Development history
The FDA granted Talvey accelerated approval on August 9, 2023, the same day the shared Tecvayli and Talvey REMS was approved[2][4].
On October 2, 2025, the FDA approved a label update that added ataxia (cerebellar ataxia and balance problems) to the neurologic warnings and dose-adjustment guidance[3]. On March 5, 2026, the FDA removed the communication plan from the shared REMS while keeping the restricted program[4]. Drugs@FDA lists further Talvey REMS modifications approved on March 5, 2026 and May 6, 2026[2].
The current label still describes an accelerated approval that depends on confirmatory trials, and it still requires a hospital stay after every step-up dose[1]. MonumenTAL-3 results were published online in the New England Journal of Medicine on June 13, 2026[6].
Explore Multiple Myeloma trials
Other Multiple Myeloma treatments
Talvey is one of 4 FDA-approved bispecific T-cell engagers for myeloma and the only one that targets GPRC5D; Tecvayli, Elrexfio and Lynozyfic target BCMA[1][9][10][11]. All 4 labels carry the same type of boxed warning for CRS and neurologic toxicity and require a REMS program[1][9][10][11]. Talvey's label adds warnings for mouth problems, weight loss and skin changes that the BCMA bispecific labels do not list as separate warnings[1][9][10][11]. No trial has compared the bispecific antibodies with each other.
Common questions about Talquetamab-tgvs
▸What is Talquetamab-tgvs (Talvey)?
Talvey (talquetamab-tgvs) is a bispecific antibody injection that targets GPRC5D, for adults whose multiple myeloma came back or stopped responding after at least 4 prior lines of therapy[1]. The FDA granted Talvey accelerated approval on August 9, 2023, based on response rates, so continued approval may depend on a confirmatory trial[2][1]. In MonumenTAL-1, 73% of 100 people on the weekly dose and 73.6% of 87 people on the every-2-week dose responded[1]. Talvey carries a boxed warning for cytokine release syndrome and neurologic toxicity, including ICANS, and is given only through the Tecvayli and Talvey REMS program[1]. Talvey is not approved for earlier lines of therapy, although the MonumenTAL-3 trial of Talvey with daratumumab was published in 2026[1][6].
▸How does Talquetamab-tgvs work?
Talvey is a bispecific antibody with 2 different binding arms[1]. One arm binds GPRC5D (G protein-coupled receptor class C group 5 member D), a protein on myeloma cells and normal plasma cells[1]. The other arm binds CD3 on T cells, the immune cells that kill abnormal cells[1].
By bridging the 2 cells, Talvey switches the T cell on, which releases inflammatory cytokines and destroys the myeloma cell[1]. GPRC5D is a different target from BCMA, the protein used by Tecvayli, Elrexfio and Lynozyfic[1][9].
GPRC5D is also found in healthy keratinized tissue of the skin and tongue, according to the label[1]. Taste changes, mouth problems, skin peeling and nail changes are common side effects of Talvey[1].
▸What are the side effects of Talquetamab-tgvs?
Talvey 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]. In the clinical trial, CRS occurred in 76% of people at the recommended doses, mostly grade 1 or 2[1]. Neurologic toxicity occurred in 55%, with grade 3 or 4 events in 6%, and ICANS in 9%[1]. In October 2025 the label added ataxia, a loss of balance and coordination, to the list of neurologic toxicities[3].
Side effects tied to GPRC5D, from the label: Mouth problems in 80%, most often altered taste (49%), dry mouth (34%), trouble swallowing (23%) and loss of taste (18%), and they had not returned to normal in 65% at the time of analysis[1] Weight loss in 62%, with a loss of 10% or more of body weight in 29%[1] Skin reactions in 62%, and nail disorders in 50%[1]
Other serious risks include infections (serious in 16%, fatal in 1.5%), low neutrophils (grade 3 or 4 in 35%), low platelets (grade 3 or 4 in 22%) and liver injury[1]. Talvey 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 Talquetamab-tgvs taken?
Talvey is an injection under the skin given by a qualified healthcare professional, with the dose based on actual body weight[1]. The label offers 2 schedules, each starting with step-up doses to lower the risk of CRS[1].
The 2 schedules:
- Weekly: 0.01mg/kg on day 1, 0.06mg/kg on day 4, then 0.4mg/kg on day 7 and once a week after that[1]
- Every 2 weeks: 0.01mg/kg, 0.06mg/kg and 0.4mg/kg as step-up doses, then 0.8mg/kg as the first treatment dose and every 2 weeks after that[1]
The label calls for a 48-hour hospital stay after every dose in the step-up schedule, which the Medication Guide says includes the first full treatment dose[1]. A steroid (dexamethasone 16mg), an antihistamine (diphenhydramine 50mg) and acetaminophen are given 1 to 3 hours before each dose in the step-up schedule[1]. Treatment continues until the myeloma worsens or side effects become unacceptable[1].
Talvey is available only through the Tecvayli and Talvey REMS, which requires certified prescribers and treatment sites and gives each patient a wallet card[1]. The label advises no driving during the step-up schedule and for 48 hours after it ends[1].
▸Is Talquetamab-tgvs FDA approved?
Yes, Talquetamab-tgvs (Talvey) is FDA approved (2023) for the treatment of Multiple Myeloma.
▸Why does Talvey change your taste?
Talvey targets GPRC5D, a protein the label says is also found in healthy keratinized tissue of the skin and tongue[1].
How often: Mouth problems occurred in 80% of people, and taste changes were the most frequent[1].
Duration: The label reports a median of 43 days to resolution, but mouth problems had not returned to baseline in 65% at the time of analysis[1].
Care: The label advises supportive care, which can include a nutritionist[1].
Source: Talvey prescribing information (DailyMed)
▸How long do you stay in the hospital for Talvey?
The Talvey label calls for a 48-hour hospital stay after every dose in the step-up schedule[1].
What counts: The Medication Guide says the step-up schedule includes the smaller step-up doses and the first full treatment dose[1].
Weekly schedule: That means 3 stays, after the 0.01mg/kg, 0.06mg/kg and first 0.4mg/kg doses[1].
Every-2-week schedule: That means 4 stays, after 3 step-up doses and the first 0.8mg/kg treatment dose[1].
Driving: No driving during the step-up schedule and for 48 hours after it ends[1].
Source: Talvey prescribing information (DailyMed)
▸Can Talvey be used after CAR T therapy?
The label reports a 72% response rate in 32 people who had already received T-cell redirecting therapy, mostly CAR T[1].
Who: Of those people, 81% had CAR T therapy and 25% had a bispecific antibody[1].
Context: This was a small single-arm group, not a randomized comparison[1].
Source: Talvey prescribing information (DailyMed)
▸What did the MonumenTAL-3 trial show?
MonumenTAL-3 found longer progression-free survival with Talvey plus daratumumab, with or without pomalidomide, than with daratumumab, pomalidomide and dexamethasone[6].
Who: 864 people with relapsed or refractory myeloma after at least 1 prior line[6].
Results: The 24-month progression-free survival estimates were 81.3% and 77.6% with the Talvey combinations versus 51.2%[6].
Label: These combinations are not approved on the current US label[1].
Source: Mina et al., New England Journal of Medicine 2026; Talvey prescribing information (DailyMed)
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.) · 2025-11. TALVEY (talquetamab-tgvs) injection, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9001355e-003d-4d4e-b4ce-337e0fd14952
- U.S. Food and Drug Administration · 2026-05-06. Drugs@FDA: TALVEY, BLA 761342, approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761342
- U.S. Food and Drug Administration · 2025-10-02. BLA 761342/S-016 supplement approval: ataxia added to neurologic toxicity sections and REMS modification. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761342Orig1s016ltr.pdf
- U.S. Food and Drug Administration · 2026-03-05. BLA 761291/S-018 supplement approval, including Tecvayli and Talvey REMS modification. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761291Orig1s018ltr.pdf
- New England Journal of Medicine · 2022-12-15. Talquetamab, a T-Cell-Redirecting GPRC5D Bispecific Antibody for Multiple Myeloma. https://doi.org/10.1056/NEJMoa2204591
- New England Journal of Medicine · 2026-06-13. Talquetamab-Daratumumab in Relapsed or Refractory Myeloma. https://doi.org/10.1056/NEJMoa2604657
- ClinicalTrials.gov · 2026-11. A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma (MonumenTAL-1). https://clinicaltrials.gov/study/NCT04634552
- ClinicalTrials.gov · 2026-11. A Study Comparing Talquetamab in Combination With Daratumumab or With Daratumumab and Pomalidomide Versus Daratumumab, Pomalidomide and Dexamethasone (MonumenTAL-3). https://clinicaltrials.gov/study/NCT05455320
- 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 (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
- Johnson & Johnson · 2026-11. TALVEY withMe, Savings and Support. https://www.talvey.com/savings-support/