CDSCO Panel Approves Johnson and Johnson's Protocol Amendment proposal for Teclistamab study

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-03-02 12:00 GMT | Update On 2025-03-03 02:11 GMT

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved Johnson and Johnson's proposal for protocol amendment of the anti-cancer drug Teclistamab study.

This came after the firm presented protocol amendment 4 dated 01 October 2024 protocol no. 64007957MMY3006. This is a phase 3 randomized study comparing Teclistamab monotherapy versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in participants with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide.

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.

Teclistamab is a drug used to treat multiple myeloma in adults. It's a bispecific antibody that binds to two targets at once, helping T cells recognize and destroy myeloma cells.

At the recent SEC meeting for Oncology held on 6th February 2025, the expert panel reviewed the protocol amendment 4 dated 01 October 2024 protocol no. 64007957MMY3006.

After detailed deliberation, the committee recommended for approval of the protocol amendment as presented by the firm.

Also Read: Hetero Labs Gets CDSCO Panel Nod To Study Antipsychotic Drug Brexpiprazole Tablets

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Dr. Divya Colin

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

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CDSCO Panel Approves Johnson and Johnson's Protocol Amendment proposal for Teclistamab study

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