Last reviewed 2026-04-20 · How we verify

Talvey (TALQUETAMAB)

Talquetamab binds to the T-cell surface glycoprotein CD3, triggering a response that kills cancer cells.

Talquetamab is a small molecule modality developed by Janssen Biotech that targets the T-cell surface glycoprotein CD3. It is approved for the treatment of relapsed or refractory multiple myeloma. Talquetamab is a patented medication with a commercial status, and its key safety considerations include potential side effects such as cytokine release syndrome. The exact mechanism of action is not well understood, but it is believed to work by binding to CD3 and triggering a response that kills cancer cells. It was FDA approved in 2023.

At a glance

Mechanism of action

Talquetamab-tgvs is bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and protein-coupled receptor class group member (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.

Approved indications

• Relapsed or refractory multiple myeloma

Boxed warnings

• WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY, including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TALVEY. Initiate TALVEY treatment with step-up dosing to reduce the risk of CRS. Withhold TALVEY until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.2 , 2.5 ) , Warnings and Precautions (5.1) ] . Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and serious and life threatening or fatal reactions, can occur with TALVEY. Monitor patients for signs and symptoms of neurologic toxicity including ICANS during treatment and treat promptly. Withhold or permanently discontinue TALVEY based on severity [see Dosage and Administration (2.5) , Warnings and Precautions (5.2) ] . Because of the risk of CRS and neurologic toxicity, including ICANS, TALVEY is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS) [see Warnings and Precautions (5.3) ] . WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY, including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning. Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TALVEY. Initiate TALVEY treatment with step-up dosing to reduce the risk of CRS. Withhold TALVEY until CRS resolves or permanently discontinue based on severity. ( 2.2 , 2.5 , 5.1 ) Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and serious and life-threatening or fatal reactions, can occur in patients receiving TALVEY. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold or permanently discontinue TALVEY based on severity. ( 2.5 , 5.2 ) TALVEY is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS). ( 5.3 )

Common side effects

• Pyrexia
• Fatigue
• Pain
• Edema
• Injection site reaction
• Cytokine release syndrome
• Dysgeusia
• Dry mouth
• Dysphagia
• Diarrhea
• Stomatitis
• Nausea

Key clinical trials

• A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma (PHASE2)
• Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma (PHASE2)
• BLOOD-dose: A Platform Trial Evaluating Dose Optimization in Hematological Diseases. (PHASE4)
• A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma (PHASE1)
• Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma (PHASE1)
• 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 (PHASE3)
• A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma (PHASE1)
• A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma (PHASE2)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Talvey CI brief — competitive landscape report
• Talvey updates RSS · CI watch RSS
• Janssen Biotech portfolio CI