Merck wins FDA Breakthrough Therapy designation for calderasib

US pharma giant Merck & Co (NYSE: MRK), known as MSD outside of the USA and Canada, 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 Food and Drug Administration (FDA).

The drug is intended for the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C-mutation and expressing PD-L1 (tumor proportion score [TPS] ≥1%). This is the first Breakthrough Therapy designation for calderasib and was supported by positive data from the Phase KANDLELIT-001 trial.