CDSCO Panel Approves GSK's Proposal to Double Indian Patient Pool in Dostarlimab Trial

After detailed deliberation, the committee recommended for approval of Increase in number of patients sample size from India 50 to 100 as presented by the firm.

Dostarlimab, also known as GSK4057190A, is an investigational anti–PD-1 monoclonal antibody. It is part of a class of immunotherapy agents known as immune checkpoint inhibitors. These drugs function by blocking the programmed death-1 (PD-1) receptor pathway, a mechanism that cancer cells often exploit to avoid immune system detection. By blocking PD-1, Dostarlimab helps restore the immune system’s ability to detect and destroy tumor cells.

GlaxoSmithKline Pharmaceuticals Ltd (GSK India) is the Indian arm of the global pharmaceutical company GlaxoSmithKline plc, headquartered in the United Kingdom. GSK India is engaged in the manufacturing, marketing, and clinical development of a wide range of therapeutic products, including vaccines, oncology medicines, and specialty biologics.