CDSCO panel Approves Pfizer's Protocol Amendment Proposal for Anti-cancer Drug Elranatamab
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment of the clinical study of Elranatamab.
This came after the firm presented Protocol Amendment 4 dated 14 August 2023, Protocol no. C1071007.
The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant.
In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years
Elranatamab is a bispecific antibody used to treat adults with relapsed or refractory multiple myeloma.Elranatamab is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager.
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.
Elranatamab is a promising therapeutic antibody designed to target multiple myeloma cells. It functions as a bispecific antibody, binding both to CD3 on T-cells and to B-cell maturation antigen (BCMA) on the surface of myeloma cells.
At the recent SEC meeting for Oncology and Hematology held on 7th and 8th December 2023, the expert panel reviewed the Protocol Amendment Proposal presented by the drug major Pfizer.
After detailed deliberation, the committee recommended for approval of the protocol amendment as presented by the firm.
