GSK Gets CDSCO Panel Nod to study safety of anti-cancer drug Dostarlimab
New Delhi: Citing that the total number of evaluable patients in the study should be a minimum of 30, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has given its nod to the drug major GSK Pharma for conducting the Phase IV clinical trial of the anti-cancer drug Dostarlimab concentrate for solution for injection50mg/mL.
This came after the drug major GSK presented the proposal to conduct a Phase IV clinical study titled “Phase 4, open label, non-comparative, interventional, multicenter study to evaluate the safety of dostarlimab in adult patients in India with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regime” vide Protocol No. 221460 dated 25.07.2023.
Dostarlimab is an anti-PD-1 monoclonal antibody used in the treatment of mismatch repair deficient endometrial cancers and solid tumours with no alternative treatment options.
Dostarlimab is an IgG4 humanized monoclonal antibody targeted against the human programmed death receptor-1 (PD-1). PD-1 receptors are found on T-cells and, when activated, serve to inhibit immune responses - some cancers leverage this system by overexpressing PD-1 ligands, thereby effectively inhibiting the anti-tumor immune response that would typically attempt to destroy the cancerous cells
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