Guardant Health, Inc. (NASDAQ:GH), announces a strategic collaboration to develop and help support commercialization of a blood-based companion diagnostic (CDx) test for Amgen's AMG 510, an investigational oral therapy that inhibits KRAS G12C mutant protein, globally. Under the agreement,GuardantHealth will pursue U.S. Food and Drug Administration (FDA) Pre-Market Approval, Japan Pharmaceutical and Medical Device Agency Approval, and European CE-Mark for Guardant360®CDx as a companion diagnostic for AMG 510 in metastatic non-small cell lung cancer (NSCLC) patients with the KRAS G12C mutation.
AMG 510 is the first-in-class KRAS G12Cinhibitor to advance to the clinic, and Amgen is currently enrolling patients in a potentially registrational Phase 2 study. AMG 510 is designed to selectively and irreversibly target a specific mutant form of KRAS called G12C that is present in nearly 13 percent of all NSCLC patients1 and for whom limited targeted treatment options have existed to date. The FDA granted Orphan Drug Designation to AMG 510 for previously treated metastatic NSCLC and colorectal cancer with KRAS G12C mutation and Fast Track Designation for previously treated metastatic NSCLC with KRAS G12C mutation.