US EditionFourth NDA for Kelun-Biotech's TROP2 ADC sacituzumab tirumotecan (sac-TMT) Accepted by the Center for Drug Evaluation
- On May 21, 2025, Sichuan Kelun-Biotech announced that the NMPA's Center for Drug Evaluation accepted the fourth NDA application for sacituzumab tirumotecan targeting HR+/HER2- breast cancer in China.
- This approval was granted following encouraging results from the Phase 3 OptiTROP-Breast02 trial, which assessed sac-TMT as a single agent against chemotherapy selected by physicians in patients with advanced or metastatic hormone receptor-positive, HER2-negative breast cancer not suitable for surgical removal.
- The study showed sac-TMT significantly improved progression-free survival and reduced the risk of progression or death, with a blinded independent review committee confirming results and a supportive trend in overall survival.
- The NMPA included the application in its priority review process announced on May 16, 2024, marking the fourth sac-TMT indication subject to this expedited review after three prior approvals under the same pathway.
- Kelun-Biotech, led by CEO Dr. Michael Ge, aims to continue expanding sac-TMT’s clinical indications globally to address unmet oncology needs, supported by over 30 ongoing innovative drug projects and global collaboration with MSD.
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Fourth NDA for Kelun-Biotech's TROP2 ADC sacituzumab tirumotecan (sac-TMT) Accepted by the Center for Drug Evaluation
CHENGDU, China, May 21, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that a new indication application (the "Application") for the Company's trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870)…
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