CDSCO Panel Approves Pfizer Protocol Amendment proposal to study anti-cancer drug Elranatamab
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Pfizer's protocol amendment proposal for the clinical trial titled "A Phase 3 Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant."
This came after the firm presented protocol amendment 5 dated 10 June 2024, protocol no. C1071007. This is a randomized, 2-arm, phase 3 study of elranatamab (PF-06863135) versus lenalidomide in patients with newly diagnosed multiple myeloma after undergoing autologous stem-cell transplantation.
Elranatamab is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. It is a humanized immunoglobulin 2-alanine kappa antibody derived from two monoclonal antibodies (mAbs), an anti-BCMA mAb and an anti-CD3 mAb, each of which contributes one heavy chain and one light chain to drug structure. The resulting 4-chain bispecific antibody is covalently linked via five inter-chain disulfide bonds.
Elranatamab-bcmm is used to treat multiple myeloma (a type of cancer of the bone marrow) that has returned or that did not respond to at least 4 other treatments.
At the recent SEC meeting for Oncology held on 23rd October 2024, the expert panel reviewed protocol amendment 5 dated 10 June 2024 protocol no.C1071007.
After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.
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