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

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