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Talquetamab

  • Antibody medicine
  • Still being tested
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Talquetamab does in the body

TALVEY 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.

From the FDA-approved label: Talquetamab-tgvs is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and G protein-coupled receptor class C group 5 member D (GPRC5D) expressed on the surface of multiple myeloma cells and non-malignant plasma cells, as well as healthy tissues such as epithelial cells in keratinized tissues of the skin and tongue. In vitro, talquetamab-tgvs activated T-cells caused the release of proinflammatory cytokines and resulted in the lysis of multiple myeloma cells. Talquetamab-tgvs had anti-tumor activity in mouse models of multiple myeloma.

Why people take it. TALVEY 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.

What happened in people

RNAWiki has not yet published a reviewed conclusion for this use.

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as protein.

    FDA substance registry · 4W3KFI3TN3 · read 2026-08-29

Where each sentence above came from

The use the label states, quoted from it. No plain-language version of this sentence has been written.

The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.

No statement of the main limit is recorded.

The four opening statements run to 178 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

Placebo

A placebo is a dummy treatment given so the real one can be compared with it.

A picture of it, and where the picture fails

A placebo is like a blank control in an experiment.

Where that stops being true. A blank does nothing. People given a placebo often do get better.

What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.

An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

Where that stops being true. A race has one winner. A study can show both arms improved.

What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.

The control condition against which the experimental intervention is assessed.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Progression Free Survival (PFS)

The study did not show it

Who was studied
NCT05552222
How many people
1590
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

iFIT1: Progression-free survival (PFS)

The study did not show it

Who was studied
NCT07649525
How many people
1226
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Progression-Free Survival (PFS)

The study did not show it

Who was studied
NCT05455320
How many people
864
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Progression Free Survival (PFS)

The study did not show it

Who was studied
NCT06208150
How many people
838
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Overall Response Rate (ORR)

The study did not show it

Who was studied
NCT04634552
How many people
510
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Overall survival

The study did not show it

Who was studied
NCT07474961
How many people
400
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • TALVEY 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 [see Clinical Studies (14) ].

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “The safety and efficacy of TALVEY have not been established in pediatric patients.”

    US prescribing information · 9001355e-003d-4d4e-b4ce-337e0fd14952 · read 2026-08-30

  • On older people, the label states: “Clinical studies did not include sufficient numbers of patients 75 years of age or over to determine whether they respond differently from younger patients.”

    US prescribing information · 9001355e-003d-4d4e-b4ce-337e0fd14952 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Based on the mechanism of action, TALVEY may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] .”

    US prescribing information · 9001355e-003d-4d4e-b4ce-337e0fd14952 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of talquetamab-tgvs in human milk, the effect on the breastfed child, or the effect on milk production.”

    US prescribing information · 9001355e-003d-4d4e-b4ce-337e0fd14952 · read 2026-08-30

Where the result stopped carrying

  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Still being tested

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Subcutaneous

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S1, S3, S4, S5, S6.

No source is stored against this line.

What is in the pack

Sold as injection, given by the subcutaneous route.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeNothing found in the sources checked

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Subcutaneous

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 5 products list this as an active ingredient in the United States drug directory. 5 of them contain it and nothing else.

    FDA National Drug Code directory · 65267-901 · read 2026-08-29

  • They are sold as injection, liquid and solution, taken subcutaneous.

    FDA National Drug Code directory · 65267-901 · read 2026-08-29

  • 1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 9001355e-003d-4d4e-b4ce-337e0fd14952 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 9001355e-003d-4d4e-b4ce-337e0fd14952 · read 2026-08-29

  • TALVEY is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS Injection 3 mg/1.5 mL (2 mg/mL) in a single-dose vial ( 3 ) 40 mg/mL in a single-dose vial ( 3 ) Injection 3 mg/1.5 mL (2 mg/mL) colorless to light yellow solution in a single-dose vial 40 m…, recorded as fda label in effect 2025-10-08 in the United States.

    US prescribing information · 9001355e-003d-4d4e-b4ce-337e0fd14952 · read 2026-08-30

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Talquetamab studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

How much did people take in the studies?

The sources RNAWiki checked hold nothing for this field.

Why it matters. A result belongs to an amount. Without the amount the result floats free.

What would answer it

A stored source that records it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Talquetamab are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Where else this substance is registered

FDA substance identifier (UNII)
4W3KFI3TN3
RxNorm concept
2644452

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Quoted from a stored source.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S1, S3, S4, S5, S6.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • The earliest marketing start date recorded for a listed product is 20230809.

    FDA National Drug Code directory · 65267-901 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

9 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What was measured, goal by goal — found nothing in the sources checked.
  • How close this is to real life — found nothing in the sources checked.
  • The path through the body — found nothing in the sources checked.
  • Felt, measured, or meaningful — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • Claims that go past the evidence — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

Recorded evidence blocks (8)

On the Talquetamab label: indicated for what?

"TALVEY 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…": indications and usage on Talquetamab's label. DailyMed label · 9001355e-003d-4d4e-b4ce-337e0fd14952 · 2025-10-08

41 registered trials of Talquetamab — at which phases?

Registered studies posting no result
41 of 41

41 registered studies of Talquetamab: 20 phase2, 12 phase1, 6 phase3, 4 na or unstated, 1 na. CLINICALTRIALS_SNAPSHOT · 2026-09-01

15 with a PubMed record

Show the evidence
  • phase2
    20
  • phase1
    12
  • phase3
    6
  • na or unstated
    4
  • na
    1
  • recruiting
    21
6 more recorded rows
  • active not recruiting
    11
  • not yet recruiting
    4
  • completed
    2
  • approved for marketing
    1
  • no longer available
    1
  • withdrawn
    1

recorded 2026-09-01 · last checked 2026-09-04

Why did Talquetamab's trial NCT05461209 stop?

1 recorded trial of Talquetamab stopped. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Business Decision"; 1 of 41 registered studies

Show the evidence
  • Trial NCT05461209
    withdrawn; "Business Decision"

recorded 2026-09-01 · last checked 2026-09-04

Talquetamab's half-life is 16 weeks — which schedules were studied?

16 weeks, the half-life Talquetamab's label states: "The mean (CV%) terminal half-life was 8.4 (41%) days after the first treatment dose and 12.2 (49%) days at 16 weeks after the first treatment dose." DailyMed label · 9001355e-003d-4d4e-b4ce-337e0fd14952 · 2025-10-08

bioavailability 59 %.

Show the evidence
  • half life pharmacokinetics
    16 weeks; The mean (CV%) terminal half-life was 8.4 (41%) days after the first treatment dose and 12.2 (49%) days at 16 weeks after the first treatment dose.
  • bioavailability pharmacokinetics
    59 %; C max 4.4 1.8 C trough 4.6 2.3 C avg 5.1 2.0 Absorption The geometric mean (coefficient of variation [CV] %) bioavailability of talquetamab-tgvs was 59% (22%) when administered subcutaneously.
  • metabolism pharmacokinetics
    Metabolism Talquetamab-tgvs is expected to be metabolized into small peptides by catabolic pathways.

recorded 2025-10-08 · last checked 2026-09-04

Which running trial of Talquetamab could settle lifespan?

NCT05455320 measures Progression-Free Survival (PFS), reading out 2028-05-25.

5 open trials; n 864; "A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants…"

Show the evidence

Trial

  • NCT05455320
    "A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment"; n 864; "Progression-Free Survival (PFS)"; 2028-05-25
  • NCT06208150
    "A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide"; n 838; "Progression Free Survival (PFS)"; 2028-12-31
  • NCT05552222
    "A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma"; n 1590; "Progression Free Survival (PFS)"; 2033-10-28
  • NCT07107529
    "Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab."; n 150; "Progression Free Survival (PFS) per IMWG criteria"; 2034-02
  • NCT07649525
    "Personalising Treatment for Myeloma Patients Based on Initial Response to NHS Treatment and Their Overall Fitness Level"; n 1226; "iFIT1: Progression-free survival (PFS)"; 2037-06

At the median, Talquetamab's trials enrolled 50 people — anything larger?

Median enrolment
50
Largest enrolment
1590
Registered trials counted
39

What do 25 spontaneous reports say about Talquetamab — and not say?

These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Talquetamab appears in spontaneous reports to regulators. Across the 6 most-reported reaction terms, 25 reaction mentions were counted: dysgeusia 7; cytokine release syndrome 5; plasma cell myeloma 4; skin exfoliation 4. FAERS via Open Targets · CHEMBL4594503 · 2026-06-24

Show the evidence
  • dysgeusia
    7
  • cytokine release syndrome
    5
  • plasma cell myeloma
    4
  • skin exfoliation
    4
  • mucosal inflammation
    3
  • immune effector cell-associated neurotoxicity syndrome
    2

recorded 2026-06-24 · last checked 2026-09-04

Which 6 reactions does Talquetamab's label not list?

cytokine release syndrome, dysgeusia and immune effector cell-associated neurotoxicity syndrome and 3 more reported for Talquetamab, absent from its label. FAERS via Open Targets · CHEMBL4594503 · 2026-06-24

2 label terms; 6 reported and unlisted; 9001355e-003d-4d4e-b4ce-337e0fd14952

Show the evidence
  • cytokine release syndrome
    count not stated
  • dysgeusia
    count not stated
  • immune effector cell-associated neurotoxicity syndrome
    count not stated
  • mucosal inflammation
    count not stated
  • plasma cell myeloma
    count not stated
  • skin exfoliation
    count not stated

recorded 2026-06-24 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL4594503
CAS number
2226212-40-2
RxCUI
2644452
Development code
JNJ-63483043, JNJ-64407564
Also called
Talquetamab-tgvs, tal, IMMUNOGLOBULIN G4-KAPPA/G4-LAMBDA, ANTI-(HOMO SAPIENS GPRC5D (G PROTEIN-COUPLED RECEPTOR CLASS C GROUP 5 MEMBER D)), AND ANTI-(HOMO SAPIENS CD3E (CD3 EPSILON, LEU-4)), HUMANIZED AND CHIMERIC MONOCLONAL ANTIBODY, BISPECIFIC, Immunoglobulin G4 [233-proline,239-alanine,240-alanine,410-leucine,414-lysine], anti-(human CD3 antigen) (human monoclonal JNJ-63483043 γ4-chain), disulfide with human monoclonal JNJ-63483043 λ-chain, (231→224′), (234→227′)-bis(disulfide) with immunoglobulin G4 [226-proline,232-alanine,233-alanine] anti-(human G protein-coupled receptor GPRC5D) (human monoclonal JNJ-64386972 γ4-chain) disulfide with human monoclonal JNJ-64386972 λ-chain, Immunoglobulin G4-kappa/G4-lambda, anti-[Homo sapiens GPRC5D (G protein-coupled receptor class C group 5 member D)], and anti-[Homo sapiens CD3E (CD3 epsilon, Leu-4)], humanized and chimeric monoclonal antibody; bispecific gamma4 heavy chain humanized anti-GPRC5D (1-445) [VH (Homo sapiens IGHV1-18*01 (89.8%) -(IGHD) -IGHJ4*01 (92.9%)) [8.8.11] (1-118) -Homo sapiens IGHG4*01 (CH1 (119-216), hinge 1-12 S10>P (226) (217-228), CH2 F1.3>A (232), L1.2>A (233) (229-338), CH3 (339-443), CHS (444-445)) (119-445)], (132-214')-disulfide with kappa light chain humanized antiGPRC5D (1'-214') [V-KAPPA (Homo sapiens IGKV1-17*02 (85.3%) -IGKJ2*01 (100%)) [6.3.9] (1'-107') -Homo sapiens IGKC*01 (100%), Km3 A45.1 (153), V101 (191) (108'-214’)]; gamma4 heavy chain chimeric anti-CD3E (1-452) [VH (Mus musculus IGHV10-1*02 (89.8%)/Homo sapiens IGHV3-72*01 (88.0%) -(IGHD) -IGHJ6*01 (90.9%)) [8.10.16] (1-125) -Homo sapiens IGHG4*01 (CH1 (126-223), hinge 1-12 S10>P (233) (224-235), CH2 F1.3>A (239), L1.2>A (240) (236-345), CH3 F85.1>L (410), R88>K (414) (346-450), CHS (451-452)) (126-452)], (139-214')-disulfide with lambda light chain humanized anti-CD3E (1'-215') [V-LAMBDA (Homo sapiens IGLV7-43*01 (81.9%) -IGLJ3*02 (100%)) [9.3.9] (1'-109') -Homo sapiens IGLC2*01 (100%) (110'-215’)]; dimer (224-231'':227-234'')-bisdisulfide, produced in Chinese Hamster Ovary (CHO)-K1 cell line, glycoform alfa, TALQUETAMAB [USAN], Talquetamab [MI], Talquetamab [WHO-DD], Talquetamab tgvs [WHO-DD], talquetamab [INN]
Trade name
Talvey
Sources (5)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 5 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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