TOLREMO Therapeutics’ TT125-802 Secures 2 US FDA’s Fast-Track Designation for NSCLC with EGFR & KRAS-G12C Mutation
Shots:
- The US FDA has granted 2 FTDs to TT125-802 for NSCLC: one for EGFR exon 19 deletion or exon 21 L858R mutation pts progressing after EGFR inhibitors, & another for KRAS G12C-mutated pts progressing after KRAS G12C inhibitors
- TT125-802 is being assessed in P-I trial to evaluate its safety, tolerability, PK, & efficacy in pts with advanced solid tumors
- TT125-802 is an oral CBP/p300 inhibitor targeting cancer survival & resistance pathways, which showed superior efficacy & safety in P-I trial as presented at ASCO’25, with clinical monotx. activity in solid tumors & no thrombocytopenia
Ref: TOLREMO Therapeutics | Image: TOLREMO Therapeutics | Press Release
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