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.
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