MSD Pharma Gets Conditional SEC Approval to Begin Phase III Trial of Sacituzumab Tirumotecan
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission to MSD Pharmaceuticals to conduct a Phase III clinical trial of its investigational product Sacituzumab Tirumotecan, subject to key conditions.
The conditions include that the firm should submit safety data for the completed Induction phase, and the firm should increase the number of subjects in India.
This came after the firm presented phase III clinical study protocol no.: MK-2870-036 Version No. 00 dated 22-JUL-2025.
Sacituzumab tirumotecan is a recombinant humanized IgG1 anti-TROP2 monoclonal antibody conjugated to a topoisomerase I inhibitor.
Sacituzumab tirumotecan was progressed as an oncology clinical candidate. The Chinese drug regulator (NMPA) approved sacituzumab tirumotecan (Jiataile) in November 2024 to treat advanced triple-negative breast cancer. The FDA granted sacituzumab tirumotecan breakthrough designation in December 2024, making it available as an option for pretreated advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) harboring EGFR mutations.
At the recent SEC meeting for oncology, the expert panel reviewed the phase III clinical study protocol no.: MK-2870-036 Version No. 00 dated 22-JUL-2025.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial subject to the following condition:
1. The firm shall submit safety data for the completed Induction phase.
2. Increase the number of subjects in India.
