CDSCO Panel Approves GSK's Proposal to Double Indian Patient Pool in Dostarlimab Trial
New Delhi: In a recent regulatory development, the Subject Expert Committee (SEC) under the Oncology division of the Central Drugs Standard Control Organization (CDSCO) has granted approval to GSK Pharma India Private Limited for increasing the Indian patient sample size in an ongoing clinical trial of GSK4057190A (Dostarlimab).
The matter was discussed as part of an online submission (39414) under application number CT/150/23. The firm presented its proposal to increase the number of Indian patients enrolled in the trial under Protocol No. 221530, from 50 to 100 participants.
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.
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