Guardant360 CDx can now identify patients eligible for zongertinib, the first targeted therapy approved as an initial treatment option for HER2-mutant advanced non-small cell lung cancer.
Guardant Health announced that the US Food and Drug Administration (FDA) approved Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim’s Hernexeos (zongertinib tablets), the first targeted therapy for adults with HER2 (ERBB2)-mutant advanced non-small cell lung cancer as an initial treatment option.
The approval allows the liquid biopsy test, which analyzes circulating tumor DNA from a blood draw, to identify patients with HER2 tyrosine kinase domain activating mutations who may be eligible for the treatment. Hernexeos is indicated for adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have these specific mutations, as detected by an FDA-authorized test.
This indication received accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial.
“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,” says Helmy Eltoukhy, Guardant Health chairman and CEO, in a release. “Guardant360 CDx has been at the forefront of enabling comprehensive genomic profiling through a simple blood draw, helping clinicians identify actionable mutations in genes such as HER2 with speed and accuracy.”
The test detects tumor-derived alterations in circulating cell-free DNA to help clinicians match patients to targeted therapies, biomarkers, and clinical trials. It was the first FDA-approved liquid biopsy to provide genomic profiling across multiple tumor types.
“Companion diagnostics are essential to personalized lung cancer care, guiding biomarker-driven treatment decisions,” says Vicky Brown, US therapeutic area head for oncology and emerging areas at Boehringer Ingelheim, in a release. “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.”
Non-small cell lung cancer is the most common type of lung cancer. A subset of patients carries HER2 mutations, which are associated with an aggressive disease course and a poor prognosis. Blood-based testing offers a less invasive alternative to tissue biopsy, which can be challenging to perform in cases of advanced disease.
This latest FDA approval marks the 27th companion diagnostic indication for the platform across multiple tumor types globally. The test currently has broad coverage by Medicare and commercial payers, representing more than 300 million covered lives, according to Guardant Health.
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