Earlier, MSD (MRK.US) reached a cooperation agreement with Colombotech (06990), which granted MSD the exclusive right to develop, produce and commercialize SAC-TMT outside of Greater China.
Zhitong Finance App learned that MSD (MRK.US) announced today that the US FDA has granted breakthrough therapy certification for the antibody-conjugated drug (ADC) sacituzumab tirumotecan (SAC-TMT) under development to treat patients with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. These patients' diseases progressed after receiving tyrosine kinase inhibitors (TKI) and platinum-containing chemotherapy. SAC-TMT is a TROP2 targeted ADC under development developed by MSD in collaboration with Colombotech (06990). According to the press release, this is the first time the treatment has been certified as a breakthrough therapy by the US FDA.
Sac-TMT is a combination of the trop2-targeting monoclonal antibody sacituzumab, a topoisomerase 1 inhibitor class cytotoxic payload, and a novel, hydrolyzable ligand. TROP2 is highly expressed in tumors of various epithelial origin and can promote tumor cell proliferation, invasion and metastasis. SAC-TMT was first developed by Collumbotai and has recently been approved for marketing by China's National Drug Administration (NMPA) to treat adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). These patients have received at least two systemic treatments (at least one for advanced or metastatic disease). Earlier, MSD reached a cooperation agreement with Colombo Thai, which granted MSD the exclusive right to develop, manufacture and commercialize SAC-TMT outside of Greater China.
