FDA Approves Guardant Test as Companion Diagnostic for First-Line Lung Cancer Drug
The liquid biopsy test will identify patients with HER2 (ERBB2) mutations eligible for Boehringer Ingelheim's newly approved first-line non-small cell lung cancer treatment.
Guardant Health said on June 11 that the FDA has approved its Guardant360 CDx liquid biopsy test as a companion diagnostic for Boehringer Ingelheim’s Hernexeos (zongertinib), a targeted therapy for adults with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC) as an initial treatment option.
“Companion diagnostics are essential to personalized lung cancer care, guiding biomarker-driven treatment decisions,” Vicky Brown, US Therapeutic Area Head for Oncology and Emerging Areas at Boehringer Ingelheim, said in a statement. “Guardant360 CDx will help identify patients with HER2-mutant advanced non-small cell lung cancer and connect eligible patients to the appropriate targeted therapy when timely treatment decisions matter most.”
Hernexeos is indicated for adult patients with unresectable or metastatic non-squamous NSCLC whose tumors carry those mutations, as detected by an FDA-authorized test. The indication was granted under accelerated approval based on objective response rate and duration of response, with continued approval contingent on verification of clinical benefit in a confirmatory trial.
NSCLC is the most common form of lung cancer. HER2-mutant NSCLC is considered an aggressive subtype associated with poor prognosis. Blood-based testing offers a faster, less invasive alternative to tissue biopsy, which can be difficult to obtain in advanced disease.
“This approval highlights the growing impact of liquid biopsy across advanced cancer care and underscores the utility of Guardant360 CDx to ensuring more patients can be matched to the right therapy at the right time,” Helmy Eltoukhy, Guardant Health co-CEO and cofounder, said in a statement.
The approval marks the 27th companion diagnostic indication for Guardant360 CDx across multiple tumor types globally.