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TECVAYLI (TECLISTAMAB-CQYV)
TECVAYLI (generic name: TECLISTAMAB-CQYV) is a drug developed by JANSSEN BIOTECH. It is currently FDA-approved for Relapsed or Refractory Multiple Myeloma (Combination Therapy), Relapsed or Refractory Multiple Myeloma (Monotherapy).
Teclistamab is an antibody that targets the T cell surface glycoprotein CD3, and it is being studied in clinical trials for multiple myeloma, amyloid light-chain amyloidosis, Waldenstrom macroglobulinaemia, recurrent multiple myeloma, and refractory multiple myeloma.
At a glance
| Generic name | TECLISTAMAB-CQYV |
|---|---|
| Sponsor | JANSSEN BIOTECH |
| Target | Tumor necrosis factor receptor superfamily member 17, T-cell surface glycoprotein CD3 |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Approved indications
- Relapsed or Refractory Multiple Myeloma (Combination Therapy)
- Relapsed or Refractory Multiple Myeloma (Monotherapy)
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 TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.5) and Warnings and Precautions (5.1) ] . Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening, or fatal reactions, can occur in patients receiving TECVAYLI. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity [see Dosage and Administration (2.5) and Warnings and Precautions (5.2) ] . Because of the risk of CRS and neurologic toxicity, including ICANS, TECVAYLI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TECVAYLI and TALVEY 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 TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity. ( 2.1 , 2.5 , 5.1 ) Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity. ( 2.5 , 5.2 ) TECVAYLI is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS). ( 5.3 )
Common side effects
- Hypogammaglobulinemia
- Upper respiratory tract infection
- Cytokine release syndrome
- Cough
- Diarrhea
- Musculoskeletal pain
- COVID-19
- Pneumonia
- Injection site reaction
- Fatigue
- Pyrexia
- Headache
Serious adverse events
- Pneumonia
- Upper respiratory tract infection
- Cytokine release syndrome
- COVID-19
- Sepsis
- Second primary malignancy
- Pyrexia
- Febrile neutropenia
- Gastroenteritis
- Myocardial infarction
Key clinical trials
- Prospective Observational Study on the Clinical Efficacy of Teclistamab in Patients With Relapsed and Refractory Multiple Myeloma in Belgium (N/A)
- Outpatient-based Teclistamab Step-up Dosing in Patients With Relapsed/Refractory Multiple Myeloma: Process Development in Academic and Community Centres, and Evaluating Impact on Caregiver Burden (Phase 4)
- A Phase 2 Study Exploring the Use of Bispecific Antibodies to Improve Progression Free Survival in Patients With High-Risk Newly Diagnosed Multiple Myeloma (MMulti-Immune HR) (Phase 2)
- Phase 1b Study of Teclistamab in Relapsed/Refractory Plasmablastic Lymphoma (Phase 1)
- Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma (Phase 2)
- Phase 1b Study of ST-067 (Decoy-Resistant IL-18) With Teclistamab in Multiple Myeloma (Phase 1)
- 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, Pomali (Phase 3)
- A Phase 1b Trial of Teclistamab in Combination With Iberdomide for Relapsed/Refractory Multiple Myeloma (Phase 1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TECVAYLI CI brief — competitive landscape report
- TECVAYLI updates RSS · CI watch RSS
- JANSSEN BIOTECH portfolio CI
Frequently asked questions about TECVAYLI
What is TECVAYLI?
TECVAYLI (TECLISTAMAB-CQYV) is a pharmaceutical drug developed by JANSSEN BIOTECH, indicated for Relapsed or Refractory Multiple Myeloma (Combination Therapy), Relapsed or Refractory Multiple Myeloma (Monotherapy).
What is TECVAYLI used for?
TECVAYLI is indicated for Relapsed or Refractory Multiple Myeloma (Combination Therapy), Relapsed or Refractory Multiple Myeloma (Monotherapy).
Who makes TECVAYLI?
TECVAYLI is developed and marketed by JANSSEN BIOTECH (see full JANSSEN BIOTECH pipeline at /company/johnson-johnson).
What is the generic name of TECVAYLI?
TECLISTAMAB-CQYV is the generic (nonproprietary) name of TECVAYLI.
What development phase is TECVAYLI in?
TECVAYLI is FDA-approved (marketed).
What are the side effects of TECVAYLI?
Common side effects of TECVAYLI include Hypogammaglobulinemia, Upper respiratory tract infection, Cytokine release syndrome, Cough, Diarrhea, Musculoskeletal pain. Serious adverse events: Pneumonia, Upper respiratory tract infection, Cytokine release syndrome, COVID-19.
What does TECVAYLI target?
TECVAYLI targets Tumor necrosis factor receptor superfamily member 17, T-cell surface glycoprotein CD3.
Related
- Target: All drugs targeting Tumor necrosis factor receptor superfamily member 17, T-cell surface glycoprotein CD3
- Manufacturer: JANSSEN BIOTECH — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Relapsed or Refractory Multiple Myeloma (Combination Therapy)
- Indication: Drugs for Relapsed or Refractory Multiple Myeloma (Monotherapy)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing