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

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.

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