Posted by Michael Wonder on 29 Aug 2025
Tolremo Therapeutics receives two FDA fast track designations for TT125-802 in pretreated, advanced or metastatic NSCLC with either an EGFR or a KRAS G12C mutation
28 August 2025 - – Tolremo Therapeutics today announced that their lead candidate, TT125-802, received two fast track designations from the US FDA for the treatment of non-small cell lung cancer.
One fast track designation was granted for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with an epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutation, with disease progression on at least one line of prior therapy including an EGFR inhibitor.
The second fast track designation was granted for the treatment of patients with locally advanced or metastatic kirstin rat sarcoma viral oncogene homolog (KRAS) G12C mutated non-small cell lung cancer, with disease progression on at least one line of prior therapy including a KRAS G12C inhibitor.
