FAB Supports Kelun-Biotech’s ADC Sacituzumab Tirumotecan for Injection in Securing Its Third Indication Approval!

On October 11, 2025, the NMPA website showed that the marketing application for the third indication of Kelun-Biotech's TROP2-targeting antibody-drug conjugate (ADC), Sacituzumab Tirumotecan for Injection, has been approved. It is indicated for the treatment of adult patients with EGFR mutation-positive locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed following prior epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy.
FAB, as China’s leading medical imaging CRO, provided comprehensive Independent Review Committee (IRC) services for the Phase III clinical study of this drug.

Source: NMPA

This approval is based on a randomized, open-label, multicenter Phase III clinical study (OptiTROP-Lung04). The OptiTROP-Lung04 study aimed to evaluate the efficacy and safety of sacituzumab tirumotecan (sac-TMT) monotherapy administered intravenously at 5mg/kg every two weeks (Q2W) compared to pemetrexed plus platinum-based chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who had failed prior EGFR-TKI therapy. This is the first global Phase III clinical study conducted in China to demonstrate significant overall survival (OS) benefit of an ADC compared to platinum-doublet chemotherapy in EGFR-mutated NSCLC resistant to TKIs. Sacituzumab tirumotecan (sac-TMT) demonstrated statistically significant and clinically meaningful improvements in both OS and progression-free survival (PFS). Importantly, it is also currently the only approved non-platinum-based chemotherapy monotherapy regimen for NSCLC following TKI treatment failure.

Source: Kelun-Biotech

As a long-term partner, FAB was responsible for the independent central image review work supporting the pivotal study for this new indication approval. Leveraging its professional expertise in lung cancer imaging evaluation, and supported by its senior team of image review experts, efficient and collaborative project operations team, and medical support capabilities, FAB provided robust assurance for the assessment of key efficacy endpoints and data delivery, effectively facilitating the smooth review and final approval of the study. This successful approval brings the cumulative number of projects supported by FAB to 44, reaffirming its substantial experience and continuous contributions in the field of clinical independent image review.

In the Phase III clinical trial for this project, the study covered 66 research sites across China and enrolled 376 subjects. Addressing the specific needs of the project, FAB's self-developed, integrated electronic system covered the entire chain—including image data transfer, anonymization processing, quality control and query, blinded image review, and data storage—ensuring the standardization of the evaluation process and data integrity.

It is worth noting that in terms of image review schedule management, FAB maintained frequent interaction with the sponsor, ensuring highly efficient progression throughout the project. Reflecting on the Data Cut-off (DCO) phase, Li Ziji, Director of Image Review Management and Operations, stated that the team faced the challenge of managing "parallel tracks" of data cleaning and image review work. The project team demonstrated a high sense of responsibility and collaborative spirit, responding to and handling various issues quickly and efficiently, while actively coordinating expert schedules. Ultimately, all image review tasks were completed on time with high quality, and the evaluation results were successfully submitted.

During the inspection by the National Medical Products Administration (NMPA), FAB also participated in on-site inspection support. Demonstrating deep familiarity with the project and professionalism, FAB actively cooperated with the sponsor, providing clear and efficient responses to expert inquiries. The process concluded with zero findings, earning high praise from the client.

With the approval of the new indication for Kelun-Biotech's ADC Sacituzumab Tirumotecan for Injection, the number of projects supported by FAB in the lung cancer field has reached 14. Among the cumulative 44 approved projects supported by FAB, the lung cancer field accounts for over 30%. This includes successful cases that have received marketing approval from four major regulatory authorities: China (NMPA), the US (FDA), the UK (MHRA), and Japan (PMDA). This not only highlights FAB's professional strength in lung cancer imaging evaluation but also confirms its exceptional ability to align its global operational capabilities with international regulatory systems.

FAB looks forward to collaborating with more partners to continuously provide high-quality independent central image review services, supporting the global research, development, and marketing process of innovative drugs, and bringing more treatment options to patients.