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 the protocol amendment proposal presented by the drug major Astrazeneca Pharma India for Volrustomig (MEDI5752) study.
This came after the firm presented protocol amendment version 3.0 dated 21 May 2024 protocol no. D798AC00001. This is a global study of volrustomig (MEDI5752) plus chemotherapy versus pembrolizumab plus chemotherapy for participants with metastatic non-small cell lung cancer. - eVOLVE-Lung02.
The official title of the study is "A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer (mNSCLC)."
Volrustomig is a monoclonal antibody that works by binding to PD-1 and CTLA-4 proteins on T cells, which activates the immune system to fight cancer. Volrustomig targets and binds to both PD-1 and CTLA4 expressed on tumor-infiltrating T lymphocytes (TILs), and inhibits the PD-1- and CTLA4-mediated downregulation of T-cell activation and proliferation.
At the recent SEC meeting with Oncology held on 9th January 2025, the expert panel reviewed the protocol amendment version 3.0 dated 21 May 2024 protocol no. D798AC00001.
After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.
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