Posted by Michael Wonder on 06 Dec 2024
FDA grants breakthrough therapy designation to sacituzumab tirumotecan for the treatment of certain patients with previously treated advanced or metastatic non-squamous non-small cell lung cancer with EGFR mutations
3 December 2024 - First breakthrough therapy designation for investigational sac-TMT in the US.
Merck today announced that the US FDA has granted breakthrough therapy designation to sacituzumab tirumotecan (sac-TMT) for the treatment of patients with advanced or metastatic non-squamous non-small cell lung cancer with epidermal growth factor receptor mutations (exon 19 deletion or exon 21 L858R) whose disease progressed on or after tyrosine kinase inhibitor and platinum-based chemotherapy.
