CDSCO opines J&J to submit details of Anticancer Drug Teclistamab approval in EU, US
New Delhi: In response to the drug major Johnson & Johnson proposal to import and market Teclistamab sterile liquid in vial 30mg/vial and 90mg/vial, the Subject Export Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit patients characteristics along with transplant history if any, treatment details and details of approval of the drug in EU and US for further deliberation.
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. it 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.
Teclistamab is a bispecific T cell engaging antibody that targets the CD3 receptor, which is expressed on the surface of T cells, and BCMA, which is expressed on malignant cells. Due to its dual binding sites, teclistamab is able to draw CD3+ T cells in close proximity to BCMA+ cells, resulting in T cell activation and T cell-mediated cytotoxicity, which is mediated by secreted perforin and various granzymes stored in the secretory vesicles of cytotoxic T cells. This effect occurs without regard to T cell receptor specificity or reliance on major histocompatibility complex (MHC) Class 1 molecules on the surface of antigen presenting cells. Ultimately, teclistamab promotes the lysis and death of BCMA+ cells.
At the recent SEC meeting for Oncology and Hematology, the expert panel reviewed the proposal presented by the firm to import and manufacture the anticancer drug Teclistamab sterile liquid in vials 30mg/vial and 90mg/vial indicated for treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody with local clinical trial waiver.
The committee noted that the firm presented the results of a Phase1/2, first-in-human, open-label, dose escalation study of teclistamab, a humanized BCMA×CD3 bispecific antibody, in subjects with relapsed or refractory multiple myeloma (MajesTEC-1) conducted in multiple countries including US and EU. The drug is currently approved in EU and US under conditional approval.
