J&J Gets CDSCO Panel Nod To Market Teclistamab sterile liquid in Vials
New Delhi: In a significant development, the drug major Johnson and Johnson has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to import and market Teclistamab sterile liquid in vials 30mg/vial and 90mg/vial indicated for the treatment of adult patients with relapsed or refractory multiple myeloma.
This came after Johnson and Johnson presented the additional information for the import and marketing of the drug Teclistamab sterile liquid in vials 30mg/vial and 90mg/vial indicated for the 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 a local clinical trial waiver.
Teclistamab is a bispecific human monoclonal antibody to the B cell maturation antigen (BCMA) and CD3, which targets the antibody to T cells (T cell engager) and is used in the treatment of refractory or relapsing multiple myeloma.
Myeloma, also called multiple myeloma, is a cancer of the plasma cells. Refractory myeloma is non-responsive to therapy or progresses within 60 days of the last line of therapy. “Relapsed myeloma” is previously treated myeloma that has progressed after prior therapy and requires new therapy
Teclistamab is a monoclonal antibody that binds to receptors on cancer cells, inducing an immune response and interfering with the ability of the cells to grow and spread. Lenalidomide is a drug that stimulates immune cells and causes cancer cell death.
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.
At the recent SEC meeting for Oncology and Hematology held on 22nd June 2023, the expert panel reviewed additional information presented by the drug major Johnson and Johnson for import and marketing of the drug Teclistamab sterile liquid in vials 30mg/vial and 90mg/vial indicated for the 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 a local clinical trial waiver.
After detailed deliberation, the committee recommended the grant of permission to import and market the drug with the waiver of Phase III clinical trial in the country with the condition that the firm should conduct a Phase IV trial.
Accordingly, the expert panel suggested the firm that the phase IV clinical trial protocol should be submitted within 3 months of import and marketing permission granted.
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