Intas Pharmaceutical Gets CDSCO Panel Nod To Manufacture, Market Anti-cancer Drug Pertuzumab
New Delhi: Intas Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the anti-cancer drug Pertuzumab concentrate for Solution for Infusion 420 mg/14 mL Vial for the indication of HER2-positive metastatic breast cancer.
However, this approval is subject to the condition that the firm shall conduct Phase IV studies in the country.
In addition, the expert panel stated that the firm should submit the Phase IV study protocol within 3 months of the grant of marketing authorization of the drug product.
This came after Intas Pharmaceuticals presented the proposal for grant of approval to manufacture and market Pertuzumab concentrate for Solution for Infusion 420 mg/14 mL Vial for the indications of HER2-positive Metastatic Breast Cancer and HER2-positive Early Breast Cancer based on the results of the Phase III clinical trial.
Pertuzumab injection is in a class of medications called monoclonal antibodies. It works by stopping the growth of cancer cells. Pertuzumab targets the extracellular dimerization domain (subdomain II) of HER2, thereby inhibiting ligand-initiated intracellular signaling via the MAP kinase and PI3K pathways. Inhibition of these pathways results in inhibition of cell growth and the initiation of apoptosis, respectively.
At the recent SEC meeting for oncology held on 6th November 2024, the expert panel reviewed the proposal for grant of approval to manufacture and market Pertuzumab concentrate for Solution for Infusion 420 mg/14 mL Vial for the indications of HER2-positive metastatic breast cancer and HER2-positive early breast cancer based on the results of the phase III clinical trial.
After detailed deliberation, the committee recommended the grant of approval to manufacture and market Pertuzumab concentrate for Solution for Infusion 420 mg/14 mL Vial for the indication of HER2-positive Metastatic Breast Cancer only with the condition that firm shall conduct Phase IV study in the country.
Accordingly, the expert panel added that the protocol to conduct the Phase IV study needs to be submitted within 3 months of the grant of marketing authorization to manufacture and market the drug product.
