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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.
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.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751