CDSCO panel Approves Astrazeneca Pharma India's Protocol Amendment proposal to study Durvalumab-Tremelimumab

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved Astrazeneca Pharma India's proposal for the protocol amendment of the clinical trial titled "A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients with Advanced Hepatocellular Carcinoma."

This came after the firm presented protocol amendment version 8.0 dated 17 June 2024 protocol no. D419CC00002.

Durvalumab is an immunotherapy drug used to treat certain types of cancer. It works by blocking a protein called PD-L1, which helps cancer cells evade the immune system. By blocking PD-L1, durvalumab allows the immune system to better recognize and attack cancer cells.

Durvalumab is a monoclonal antibody that blocks the interaction between the programmed cell death ligand 1 (PD-L1) and its receptor, programmed cell death receptor 1 (PD-1), or CD80, which are expressed on T cells and cancer cells, respectively. By preventing this interaction, durvalumab removes a brake on the immune system, allowing T cells to be activated and attack tumor cells.

Tremelimumab, sold under the brand name Imjudo, is a monoclonal antibody used in cancer treatment, specifically for hepatocellular carcinoma (HCC) and non-small cell lung cancer (NSCLC). It works by blocking the CTLA-4 protein, which helps the immune system regulate T cell activity, thereby boosting the immune response against cancer cells.

At the recent SEC meeting for Oncology held on 11th March 2025, the expert panel reviewed the protocol amendment version 8.0 dated 17 June 2024 protocol no. D419CC00002.

After detailed deliberation, the committee recommended approval of the protocol amendment as presented by the firm.

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