NMPA accepts Kelun-Biotech's sac-TMT for first-line advanced TNBC
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical $6990.HK
- Drug
- sacituzumab tirumotecan
- Indication
- first-line locally advanced or metastatic triple-negative breast cancer
China's National Medical Products Administration (NMPA) accepted Kelun-Biotech's supplemental new drug application for sacituzumab tirumotecan (sac-TMT), a TROP-2-directed antibody-drug conjugate, as first-line treatment for adults with locally advanced or metastatic triple-negative breast cancer. sac-TMT was previously approved in China for pretreated advanced TNBC and non-squamous NSCLC. Gilead holds ex-China rights to sac-TMT through a 2024 partnership; the China 1L TNBC filing is Kelun's independent regulatory activity.
What this means
Sacituzumab tirumotecan is an antibody-drug conjugate that targets a protein on cancer cells to deliver chemotherapy directly to tumors. China's NMPA has accepted the application to review this drug for previously untreated advanced triple-negative breast cancer. If approved, it could provide a new first-line treatment option for this aggressive form of the disease.