Posted by Michael Wonder on 31 May 2026
FDA grants breakthrough therapy designation for calderasib (MK-1084), an investigational KRAS G12C inhibitor, for certain patients with newly diagnosed metastatic KRAS G12C mutant non-small cell lung cancer
29 May 2026 - First breakthrough therapy designation for calderasib, supported by positive data from the Phase 1 KANDLELIT-001 trial.
Merck announced that calderasib (MK-1084), an investigational oral specific KRAS G12C inhibitor, in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, has been granted breakthrough therapy designation by the US FDA for the first-line treatment of patients with advanced or metastatic non-small cell lung cancer with KRAS G12C mutation and expressing PD-L1 (tumour proportion score ≥1%).
