Zydus Lifscience Gets CDSCO Panel Nod to Manufacture, Market Nivolumab for Metastatic Non-small Cell Lung Cancer
New Delhi: In a significant development, the drug major Zydus Life Sciences has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market Nivolumab 10mg/mL liquid solution for intravenous infusion for the indication locally advanced or metastatic non-small cell lung cancer (NSCLC).
In addition to the above, the expert panel approved the applied additional indications that are already approved for innovator products in India, subject to the condition that the firm shall conduct a Phase IV study in the country for all approved indications, including locally advanced or metastatic non-small cell lung cancer (NSCLC).
This came after Zydus Life Sciences presented their proposal for a grant of permission to manufacture and market Nivolumab 10 mg/mL liquid solution for intravenous infusion based on the results of a comparative Phase III clinical trial conducted in India to establish the efficacy, safety, pharmacokinetics, and immunogenicity of the drug product in locally advanced or metastatic non-small cell lung cancer (NSCLC).
In continuation with the above, Zydus Life Sciences also presented the proposal for approval of additional indications by way of extrapolation in line with indications approved for innovator products based on prescribing information.
Nivolumab is a PD-1 blocking antibody used to treat melanoma, non small-cell lung cancer, renal cell cancer, head and neck cancer, and Hodgkin lymphoma.
The ligands PD-L1 and PD-L2 bind to the PD-1 receptor on T-cells, inhibiting the action of these cells. Tumor cells express PD-L1 and PD-L2. Nivolumab binds to PD-1, preventing PD-L1 and PD-L2 from inhibiting the action of T-cells and and restoring a patient's tumor-specific T-cell response.
Nivolumab is used alone or with other drugs to treat certain types of classic Hodgkin lymphoma, colorectal cancer, esophageal cancer, gastroesophageal junction cancer, head and neck squamous cell carcinoma, hepatocellular carcinoma (a type of liver cancer), malignant pleural mesothelioma, melanoma, and non-small cell lung cancer.
At the recent SEC meeting for oncology held on June 18, 2024, the expert panel reviewed the proposal presented by Zydus Lifesciences for the grant of permission to manufacture and market Nivolumab 10 mg/mL liquid solution for intravenous infusion.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market Nivolumab 10 mg/mL liquid solution for intravenous infusion for the indication of locally advanced or metastatic non-small cell lung cancer (NSCLC).
Furthermore, the committee recommended approval of the applied additional indications that are already approved for innovator products in India subject to the condition that the firm shall conduct a Phase IV study in the country for all approved indications including locally advanced or metastatic non-small cell lung cancer (NSCLC).
In accordance with the above, the expert panel suggested that the protocol to conduct the Phase IV study should be submitted within three months of grant of marketing authorization permission to manufacture and market the product.
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