MSD Pharma Receives Conditional Approval for Phase III Trial of Sacituzumab Tirumotecan in India
Key Insights
MSD Pharma (search) has received conditional SEC approval to begin a Phase III trial of sacituzumab tirumotecan, an anti-TROP2 (search) antibody-drug conjugate, following review of protocol MK-2870-036.
The approval comes with two conditions: submission of safety data from the completed induction phase and increasing the number of subjects in India.
Sacituzumab tirumotecan has already gained regulatory recognition globally, with NMPA approval in China for triple-negative breast cancer (search) and FDA breakthrough designation for EGFR (search)-mutated NSCLC.
MSD Pharma (search) has received conditional approval from India's Subject Expert Committee (SEC) to initiate a Phase III clinical trial of sacituzumab tirumotecan, marking a significant step forward for this antibody-drug conjugate in the Indian market. The approval follows the company's presentation of phase III clinical study protocol no. MK-2870-036 Version No. 00 dated 22-JUL-2025.
Regulatory Approval with Conditions
The SEC oncology expert panel granted permission to conduct the trial subject to two specific conditions. First, MSD Pharma (search) must submit safety data for the completed induction phase. Second, the company is required to increase the number of subjects participating in the Indian portion of the study.
Drug Profile and Mechanism
Sacituzumab tirumotecan is a recombinant humanized IgG1 anti-TROP2 (search) monoclonal antibody conjugated to a topoisomerase I (search) inhibitor. This antibody-drug conjugate has been developed as an oncology clinical candidate, targeting the TROP2 protein that is overexpressed in various cancer types.
Global Regulatory Progress
The drug has achieved notable regulatory milestones internationally. The Chinese drug regulator (NMPA) approved sacituzumab tirumotecan under the brand name Jiataile in November 2024 for the treatment of advanced triple-negative breast cancer (search). Additionally, the FDA granted sacituzumab tirumotecan breakthrough designation in December 2024, making it available as a treatment option for pretreated advanced or metastatic nonsquamous non-small cell lung cancer (search) (NSCLC) harboring EGFR (search) mutations.
Clinical Development Strategy
The Phase III trial represents a crucial stage in the drug's development pathway, building on previous clinical data that supported the regulatory approvals in other markets. The conditional nature of the SEC approval reflects the regulatory body's commitment to ensuring robust safety data while facilitating access to promising oncology treatments for Indian patients.