Teclistamab

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.

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
Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis	2025/07/23	NCT07079423	Not Applicable	Recruiting	Peking Union Medical College Hospital
A Study to Assess Safety of Teclistamab in Indian Participants With Relapsed and Refractory Multiple Myeloma	2025/06/22	NCT07030517	Phase 4	Recruiting	Johnson & Johnson Private Limited
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)	2025/05/29	NCT06993675	Phase 2	Not yet recruiting	Noffar Bar
Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse	2025/04/29	NCT06948084	Phase 2	Not yet recruiting	National Cancer Institute (NCI)
Teclistamab in Previously Treated AL Amyloidosis	2025/04/20	NCT06935162	Phase 2	Recruiting	Peking Union Medical College Hospital
Teclistamab Plus Autologous Lymphocyte Infusion (ALI) for the Treatment of R/R Multiple Myeloma	2025/03/25	NCT06880601	Phase 2	Not yet recruiting	Gruppo Italiano Malattie EMatologiche dell'Adulto
The Norwegian Immunotherapy in Multiple Myeloma Study	2025/03/03	NCT06855121	N/A	Recruiting	St. Olavs Hospital
Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients	2025/01/03	NCT06758375	Phase 2	Recruiting	Hospital Universitario Dr. Jose E. Gonzalez
Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis	2024/11/21	NCT06699394	Not Applicable	Recruiting	Peking University People's Hospital
A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis	2024/10/21	NCT06649695	Phase 2	Recruiting	European Myeloma Network B.V.

FDA Drug Approvals

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

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Tecvayli	Janssen-Cilag International N.V.,Turnhoutseweg 30,Beerse,2340 Antwerp,Belgium	Authorised	8/23/2022

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
TECVAYLI SOLUTION FOR INJECTION 10MG/ML	Patheon Manufacturing Services LLC (Bulk production/Primary Packager)	SIN16948P	INJECTION, SOLUTION	10mg/mL	2/16/2024
TECVAYLI SOLUTION FOR INJECTION 90MG/ML	Patheon Manufacturing Services LLC (Bulk production/Primary Packager)	SIN16949P	INJECTION, SOLUTION	90mg/mL	2/16/2024

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

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	Janssen-Cilag Pty Ltd	Medicine	A	6/14/2023
TECVAYLI teclistamab 10mg/mL solution for injection vial	387621	Janssen-Cilag Pty Ltd	Medicine	A	6/14/2023

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
TECVAYLI	Janssen Inc	02539756	Solution - Subcutaneous	30 MG / 3 ML	10/20/2023
TECVAYLI	Janssen Inc	02539764	Solution - Subcutaneous	153 MG / 1.7 ML	10/20/2023

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
TECVAYLI 90 MG/ML SOLUCION INYECTABLE	Janssen-Cilag International N.V	1221675002	SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
TECVAYLI 10 MG/ML SOLUCION INYECTABLE	Janssen-Cilag International N.V	1221675001	SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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