Merck Secures FDA Breakthrough Status for Calderasib-Keytruda Lung Cancer Combo

Merck announced the FDA granted Breakthrough Therapy Designation to its investigational drug calderasib (MK-1084). The designation covers calderasib in combination with Keytruda for the first-line treatment of metastatic non-small cell lung cancer (NSCLC).

This therapy targets patients whose tumors possess the specific KRAS G12C mutation. This mutation is found in approximately 14% of patients with NSCLC adenocarcinoma.

The FDA granted the status based on positive data from the Phase 1 KANDLELIT-001 clinical trial. Breakthrough Therapy status expedites the review of medicines that show preliminary evidence of substantial improvement over available treatments.