What's Happening?
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has announced the approval of a new indication for its TROP2-directed antibody-drug conjugate, sacituzumab tirumotecan (sac-TMT), by the National Medical Products Administration (NMPA) of China. This approval is for the treatment
of adult patients with unresectable or metastatic HR+/HER2- breast cancer who have previously received endocrine therapy and at least one line of chemotherapy. The approval is based on positive results from the Phase III OptiTROP-Breast02 study, which demonstrated a significant increase in progression-free survival compared to chemotherapy. Sac-TMT is now approved for four indications in China, marking a significant milestone for Kelun-Biotech.
Why It's Important?
The approval of sac-TMT for a new indication in breast cancer treatment is significant as it offers a new therapeutic option for patients with limited treatment choices. HR+/HER2- breast cancer is a common subtype, and the new approval could improve outcomes for patients who have exhausted other therapies. This development also highlights the growing role of antibody-drug conjugates in cancer treatment, offering targeted therapy with potentially fewer side effects compared to traditional chemotherapy. The approval could enhance Kelun-Biotech's market position and expand its influence in the oncology sector.
What's Next?
Kelun-Biotech plans to continue its global clinical studies of sac-TMT, including trials in combination with pembrolizumab for chemotherapy-naïve HR+/HER2- breast cancer patients. The company is also exploring additional indications for sac-TMT in other cancer types. As sac-TMT gains more approvals, it may become a standard treatment option, potentially leading to increased adoption in clinical practice. The company’s collaboration with Merck & Co. for development outside Greater China could further expand its global reach.
