CDSCO Flags MSD Pharma's Cancer Drug Trial Over Indian Representation, Control Arm
Written By : Parthika Patel
Published On 2025-10-04 10:41 GMT | Update On 2025-10-04 10:41 GMT
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New Delhi: The Subject Expert Committee (SEC) on Oncology under the Central Drugs Standard Control Organization (CDSCO) has raised critical concerns over the Phase III clinical trial proposal of Sacituzumab Tirumotecan submitted by MSD Pharmaceuticals Pvt. Ltd., directing the company to provide detailed justifications regarding its study design and patient representation in India.
MSD Pharmaceuticals Pvt. Ltd., the Indian subsidiary of global biopharmaceutical company Merck & Co., presented its Phase III clinical trial Protocol No. MK2870-032, Version 00, dated February 18, 2025, for evaluation.
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