Submit analysis of clinical data of Asian, Indian Population: CDSCO Panel Tells AstraZeneca on Durvalumab

New Delhi: In response to the drug major AstraZeneca's proposal for the approval of additional indication of Durvalumab 120 mg/2.4 mL and 500 mg/10 mL solution, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit the subset analysis of the clinical data of Asian population and Indian population of Global clinical study(AEGEAN) conducted in the proposed indication.

In addition to the above, the expert panel stated to submit the results of the ongoing Phase IV clinical study and the status of regulatory approval of the proposed indication of Durvalumab 120 mg/2.4 mL and 500 mg/10 mL solution.

This came after the drug major AstraZeneca presented the proposal for approval of additional indication i.e.,“Durvalumab (IMFINZI) in combination with chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy after surgery, is indicated for the treatment of patients with resectable (tumours ≥ 4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements” based on the global clinical trial conducted including subjects from India.

Durvalumab injection is in a class of medications called monoclonal antibodies. It works by helping the immune system to slow or stop the growth of cancer cells. Durvalumab is an anticancer antibody that works to promote the antitumor responses mediated by immune cells. By blocking the action of PD-L1, durvalumab exerts its anticancer effects by increasing T-cell activation and enhancing the detection and ablation of tumor cells.

Durvalumab is used alone or with other drugs to treat adults with certain types of biliary tract cancer (including bile duct cancer and gallbladder cancer), hepatocellular carcinoma (a type of liver cancer), non-small cell lung cancer, and small cell lung cancer.

At the recent SEC meeting for Oncology held on 19th and 20th March 2024, the expert panel reviewed the proposal presented by the drug major AstraZeneca for the approval of the additional indication of Durvalumab (IMFINZI) based on the global clinical trial conducted including subjects from India.

The committee noted that the proposed indication is not yet approved by any regulatory authorities. Furthermore, the expert panel found that phase IV study of the drug is ongoing in India for the approved indication i.e., locally advanced, unresectable non-small cell lung cancer (NSCLC) and urothelial cancer.

After detailed deliberation, the committee recommended the firm to submit

1)subset analysis of clinical data of the Asian population and Indian population of Global clinical study(AEGEAN) conducted in the proposed indication.

2) Results of ongoing Phase IV clinical study

3) Status of regulatory approval of the proposed indication for further evaluation.

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