NMPA Accepts NDA for Sacituzumab Tirumotecan (sac-TMT) IN 1L TNBC
Dr. Michael Ge, CEO of Kelun-Biotech, said, “Following the approval of sac-TMT for second-line or later treatment of TNBC based on results from the Phase III OptiTROP-Breast01 study, we are delighted to see another important milestone in the same disease area. For patients with PD-L1-negative advanced TNBC, the efficacy of traditional chemotherapy is limited, and there is an urgent clinical need for more effective and safer first-line treatment options. The positive results from the OptiTROP-Breast03 study demonstrate a clear and clinically meaningful improvement in efficacy with sac-TMT compared to chemotherapy and support the continued evaluation of sac-TMT as the first-line treatment for TNBC. We look forward to the early approval of this indication to bring a new and more effective first‑line treatment option to a broader population with advanced TNBC.”
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