CDSCO Panel Approves AstraZeneca's Protocol Amendment Proposal For Anti-cancer Drug Volrustomig study
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved AstraZeneca's protocol amendment proposal for study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical).
This came after the firm presented protocol amendment version 4.0 dated 03 September 2024 protocol no. D7984C00002. This is a phase III, randomized, double-blind, placebo-controlled, multi-centre, global study of volrustomig in women with high-risk locally advanced cervical cancer who have not progressed following platinum-based, concurrent chemoradiation therapy (eVOLVE-Cervical).
Volrustomig is another type of immunotherapy. It works by targeting and blocking the proteins PD-L1 and CTLA-4 on the surface of T cells. Blocking these 2 proteins triggers the immune system to find and kill cancer cells.
Volrustomig is an engineered fragment crystallizable (Fc) domain bispecific human immunoglobulin G1 (IgG1) monoclonal antibody directed against the human negative immunoregulatory checkpoint receptor programmed cell death protein 1 (PD-1; PDCD1; CD279) and cytotoxic T-lymphocyte-associated antigen 4 (CTLA4; CTLA-4), with potential immune checkpoint inhibitory and antineoplastic activities.
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