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Drug

Talquetamab

Approved medicine
ClassT cell surface glycoprotein CD3 binding agentResearchOngoing clinical research

Also known as Talvey, 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-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 AN.

RxNorm2644447ChEMBLCHEMBL4594503UNII4W3KFI3TN3
30
Active clinical trials
3
Protein targets
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

64407564MMY3009: A Phase 3 Randomized Study Comparing Talquetamab in Combination With Pomalidomide (Tal-P), Talquetamab in Combination With Teclistamab (Tal-Tec), and Investigator's Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pom

Clinical trial2026-07-30Status changed to Active, not recruiting · ClinicalTrials.gov

An Open-Label, Non-Randomized, Phase II Study to Study the Efficacy of Talquetamab (JNJ-64407564) and Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma (OPTIMMAL)

Clinical trial2026-07-17Results expected Q4 2027 · ClinicalTrials.gov

Phase 2 Study of Cytokine Release Syndrome Prophylaxis With Infliximab for Teclistamab/Talquetamab Therapy in Patients With Relapsed/Refractory Myeloma

Clinical trial2026-07-08Results expected Q4 2027 · ClinicalTrials.gov

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

Clinical trial2026-07-06Results expected Q2 2027 · ClinicalTrials.gov

A Phase 1b Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Subjects With Multiple Myeloma

Clinical trial2026-07-06Results expected Q2 2027 · ClinicalTrials.gov

A Phase 2, Open-Label, Multicenter Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma

Clinical trial2026-07-06Results expected Q3 2027 · ClinicalTrials.gov

A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Different Sequences of Ciltacabtagene Autoleucel (Cilta-cel), Talquetamab SC in Combination With Daratumumab SC (Tal-D) and Teclistamab SC in Combination With Daratumumab SC (Tec-D) Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) in Participants With Standard-risk Newly Diagnosed Multiple Myeloma

Clinical trial2026-07-06Results expected Q3 2030 · ClinicalTrials.gov

A Phase 2, Open-label, Randomized Study to Evaluate GPRC5D-related Oral Events

Clinical trial2026-07-06Results expected Q2 2030 · ClinicalTrials.gov

A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy

Clinical trial2026-07-06Results expected Q2 2031 · ClinicalTrials.gov

iFIT (UK-MRA Myeloma XVIII): Immunotherapy Approaches Adapted for Fitness in Newly Diagnosed Transplant Ineligible Patients With Myeloma

Clinical trial2026-06-16Results expected Q2 2033 · ClinicalTrials.gov

EHA: J&J sharpens myeloma edge as Talvey, Darzalex Faspro combo proves its worth in earlier disease stage

Industry2026-06-12Fierce Pharma

Approval: Talvey (EMA)

Regulatory2023-08-21EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Talquetamab
Aliases & brands
TalveyIMMUNOGLOBULIN 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, BISPECIFICIMMUNOGLOBULIN 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 AN
RxNorm CUI
2644447
ChEMBL ID
CHEMBL4594503
UNII
4W3KFI3TN3
Primary mechanism
T cell surface glycoprotein CD3 binding agent
Regulatory jurisdictions
ema

Pharmacology & targets

3 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

T-cell surface glycoprotein CD3 epsilon chain
CD3E · P07766
BINDING AGENTT cell surface glycoprotein CD3 binding agent
T-cell surface glycoprotein CD3 gamma chain
CD3G · P09693
BINDING AGENTT cell surface glycoprotein CD3 binding agent
T-cell surface glycoprotein CD3 delta chain
CD3D · P04234
BINDING AGENTT cell surface glycoprotein CD3 binding agent

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2023-08-21
Latest approval
2023-08-21
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2023-08-21Approval
Approval: Talvey (EMA)
Indication: Talvey is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an… Show full indication

Talvey is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti CD38 antibody and have demonstrated disease progression on the last therapy.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

33 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
33
registered trials across all phases
LATEST COMPLETION 2026
30
Active studies
19
Recruiting
6
Late-stage (III+)
2
Completed
1
Discontinued
PHASE DISTRIBUTIONn = 33
Phase 18Phase 1 / 22Phase 217Phase 35Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

iFIT (UK-MRA Myeloma XVIII): Immunotherapy Approaches Adapted for Fitness in Newly Diagnosed Transplant Ineligible Patients With Myeloma

Not yet recruitingPH IIIKey trialUniversity of Leedsn=1,2262037

A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy

RecruitingPH IIIKey trialJanssen Research & Development, LLCn=1,5902033

64407564MMY3009: A Phase 3 Randomized Study Comparing Talquetamab in Combination With Pomalidomide (Tal-P), Talquetamab in Combination With Teclistamab (Tal-Tec), and Investigator's Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pom

Active, not recruitingPH IIIJanssen Research & Development, LLCn=8382028

A Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 1 Prior Line of Therapy

Active, not recruitingPH IIIJanssen Research & Development, LLCn=8642028

A Phase 3 Study Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory Multiple Myeloma Who Have Received at Least 4 Prior Therapies Including an Immunomodulatory Drug, a Proteasome Inhibitor, and an Anti-CD38 Antibody

WithdrawnPH IIIJanssen Research & Development, LLC2024
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.