MedPath

Teclistamab

Generic Name
Teclistamab
Brand Names
Tecvayli
Drug Type
Biotech
CAS Number
2119595-80-9
Unique Ingredient Identifier
54534MX6Z9

Overview

Teclistamab is an IgG4-PAA bispecific antibody that targets the CD3 receptor expressed on the surface of T cells and B cell maturation antigen (BCMA) expressed on malignant multiple myeloma cells. Teclistamab consists of an anti-BCMA arm and an anti-CD3 arm connected via two interchain disulfide bonds, allowing the drug to recruit CD3-expressing T cells to BCMA-expressing cells to promote T cell–mediated cytotoxicity. On August 24, 2022, the European Commission (EC) granted conditional marketing authorization of teclistamab as first-in-class bispecific antibody for the treatment of multiple myeloma, marking its first global approval. Teclistamab was later granted accelerated approval by the FDA on October 25, 2022.

Background

Teclistamab is an IgG4-PAA bispecific antibody that targets the CD3 receptor expressed on the surface of T cells and B cell maturation antigen (BCMA) expressed on malignant multiple myeloma cells. Teclistamab consists of an anti-BCMA arm and an anti-CD3 arm connected via two interchain disulfide bonds, allowing the drug to recruit CD3-expressing T cells to BCMA-expressing cells to promote T cell–mediated cytotoxicity. On August 24, 2022, the European Commission (EC) granted conditional marketing authorization of teclistamab as first-in-class bispecific antibody for the treatment of multiple myeloma, marking its first global approval. Teclistamab was later granted accelerated approval by the FDA on October 25, 2022.

Indication

Teclistamab is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. Teclistamab is approved by the EC and FDA under conditional marketing authorization and accelerated approval, respectively. New evidence for this drug will be continuously monitored and reviewed, which will affect continued approval for the drug's indication.

Associated Conditions

  • Refractory Multiple Myeloma
  • Relapsed Multiple Myeloma

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/06/22
Phase 4
Recruiting
2025/05/29
Phase 2
Not yet recruiting
Noffar Bar
2025/04/29
Phase 2
Not yet recruiting
2025/04/20
Phase 2
Recruiting
2025/03/25
Phase 2
Not yet recruiting
2025/03/03
N/A
Recruiting
St. Olavs Hospital
2025/01/03
Phase 2
Recruiting
Hospital Universitario Dr. Jose E. Gonzalez
2024/11/21
Not Applicable
Recruiting
2024/10/21
Phase 2
Not yet recruiting
European Myeloma Network B.V.
2024/09/19
Phase 1
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Janssen Biotech, Inc.
57894-450
SUBCUTANEOUS
90 mg in 1 mL
2/27/2024
Janssen Biotech, Inc.
57894-449
SUBCUTANEOUS
10 mg in 1 mL
2/27/2024

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
TECVAYLI SOLUTION FOR INJECTION 10MG/ML
SIN16948P
INJECTION, SOLUTION
10mg/mL
2/16/2024
TECVAYLI SOLUTION FOR INJECTION 90MG/ML
SIN16949P
INJECTION, SOLUTION
90mg/mL
2/16/2024

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Teclistamab Injection
国药准字SJ20240025
生物制品
注射剂
6/18/2024
Teclistamab Injection
国药准字SJ20240026
生物制品
注射剂
6/18/2024

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
TECVAYLI teclistamab 90mg/mL solution for injection vial
387622
Medicine
A
6/14/2023
TECVAYLI teclistamab 10mg/mL solution for injection vial
387621
Medicine
A
6/14/2023
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