Need More Justification: CDSCO Panel rejects J&J protocol amendment proposal for Teclistamab study
New Delhi: Citing that more justification is required, the Subject Expert Committee SEC functional under the Central Drug Standard Control Organisation (CDSCO) has rejected Johnson & Johnson's protocol amendment proposal for the anti-cancer drug Teclistamab study.
This came after the firm presented protocol amendment 3.0 dated 14 June 2023 protocol No. 64007957MMY3005.
This is a study of Teclistamab in combination with Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in combination with Daratumumab and Lenalidomide (Tal-DR) in participants with newly diagnosed multiple myeloma (MajesTEC-7).
The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).
Teclistamab is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T cell engager used to treat relapsed and refractory multiple myeloma in adults as monotherapy.
Teclistamab binds to a protein called CD3, which is found in T cells (a type of white blood cell). It also binds to a protein called BCMA, which is found on myeloma cells and some B cells (another type of white blood cell). This may help the immune system kill cancer cells.
At the recent SEC meeting for Oncology held on 21st February 2023, the expert panel reviewed the presented protocol amendment 3.0 dated 14 June 2023 protocol No. 64007957MMY3005.
After detailed deliberation, the committee opined that due to significant drug-related toxicity, the protocol amendment may not be considered at this stage and more justification is required to be submitted for further review by the committee.
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