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.”
Share:
More News
“This collaboration with Daiichi Sankyo represents an exciting milestone for our hematology franchise. Innovent has continued to expand its product footprint in this field, building a diversified portfolio and strong market presence including TYVYT® (sintilimab injection), HALPRYZA® (rituximab injection), olverembatinib, FUCASO® (Equecabtagene Autoleucel Injection), Jaypirca® (pirtobrutinib), and the addition of
“The initiation of our global Phase 3 program marks an important milestone for BL-M14D1 and reflects our commitment to bringing innovative treatment options to patients with small cell lung cancer,” said Jonathan Cheng, M.D., Chief Medical Officer of SystImmune. “Despite recent advances, outcomes for patients with extensive-stage small cell lung
Dr. Shawn M. Leland, PharmD, RPh, Board Chairman of Evexta Bio stated: “We are very pleased and excited to partner with Roche on Evexta Bio’s first clinical collaboration with rupitasertib. ER+, HER2-, ESR1-mutated breast cancer remains a significant unmet medical need. We are looking forward to being able to provide
“Advancing ACR-2316 into dose expansion is an important milestone for Acrivon, and the exciting initial clinical activity observed represents further clinical validation of our AP3 platform,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president and co-founder of Acrivon. “We rationally designed ACR-2316 using AP3 to overcome the resistance mechanisms