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  • Submit Clarification...

Submit Clarification for Weight-based calculated fixed dose: CDSCO panel Tells J&J Over Teclistamab

Dr. Divya ColinWritten by Dr. Divya Colin Published On 2023-08-21T18:00:21+05:30  |  Updated On 21 Aug 2023 6:00 PM IST
USFDA nod to JnJ Tremfya for Crohns disease
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New Delhi: Based on the proposal presented by drug major Johnson & Johnson for the protocol amendment of the anticancer drug Teclistamab, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined that the firm should submit clarification for a weight-based calculated fixed dose of the anticancer drug Teclistamab in light of earlier trials along with other regulatory approvals for review of the committee.

This came after Johnson & Johnson presented its proposal for protocol amendment vide protocol No.64007957MMY3006, amendment 1, dated 16 Feb 2023 before the committee.

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 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.

On August 24, 2022, the European Commission (EC) granted conditional marketing authorization for teclistamab as a 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.

At the recent SEC meeting Oncology and Haematology held on 10th August 2023, the expert panel reviewed the proposal presented by the drug major Johnson & Johnson for the protocol amendment vide protocol No.64007957MMY3006, amendment 1, dated 16 Feb 2023 before the committee.

After detailed deliberation, the committee opined that the firm should submit clarification for weight-based calculated fixed dose in light of earlier trials along with other regulatory approvals for review by the committee.

Also Read:Cabinet approves signing of MoU between India, Suriname in field of Medical Products Regulation

TeclistamabcdscoJohnson & Johnsonanticancer drug
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    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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