US EditionFourth NDA for Kelun-Biotech's TROP2 ADC sacituzumab tirumotecan (sac-TMT) Accepted by the Center for Drug Evaluation
- On May 21, 2025, Kelun-Biotech announced that the National Medical Products Administration's Center for Drug Evaluation in China has accepted a new indication application for sacituzumab tirumotecan to treat adults with hormone receptor–positive, HER2-negative breast cancer that is advanced and cannot be surgically removed or has spread to other parts of the body.
- The acceptance followed the positive interim results from the Phase 3 OptiTROP-Breast02 study, which compared sac-TMT monotherapy versus chemotherapy in patients who had received prior endocrine and systemic therapies, and was designated for priority review in May 2024.
- Sac-TMT showed a statistically significant reduction in progression or death risk and a beneficial overall survival trend, marking the fourth sac-TMT indication under the CDE's priority review after three prior approved indications including TNBC and EGFR-mutant NSCLC.
- In 2022, about 2,297,000 new breast cancer cases and 666,000 deaths occurred worldwide, with HR+/HER2- subtype accounting for roughly 70% and representing an unmet clinical need for effective advanced treatments.
- Kelun-Biotech, led by CEO Dr. Michael Ge, intends to continue global development of sac-TMT and other innovative drugs to meet unmet oncology needs and enhance patient outcomes worldwide.
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Kelun-Biotech Announces Breakthrough Therapy Designation Granted for Sacituzumab Tirumotecan (Sac-TMT) in Combination With Tagitanlimab in China for Certain Types of Non-Small Cell Lung Cancer
CHENGDU, China, June 10, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") today announced that its TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) (佳泰莱®) in combination with the PD-L1 monoclonal antibody tagitanlimab (科泰莱®) was granted Breakthrough Therapy Designation…
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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