newsfilter
← Latest News
Business Wire·

Guardant Health Announces Landmark FDA Approval of Guardant360® CDx as Companion Diagnostic for AstraZeneca’s ETCAMAH™ (camizestrant) in Advanced Breast Cancer

GH
  • FDA approved Guardant360 CDx as a companion diagnostic for detecting ESR1 mutations in HR-positive, HER2-negative advanced or metastatic breast cancer prior to radiographic progression.
  • The approval enables ctDNA-guided switching to camizestrant combined with a CDK4/6 inhibitor upon ESR1 mutation detection, representing the first FDA-approved liquid biopsy CDx for longitudinal testing in breast cancer.
  • Data from the Phase III SERENA-6 trial showed a 56% reduction in the risk of disease progression or death for patients switching to camizestrant-based therapy versus continuing aromatase inhibitor treatment.
  • Patients treated under this adaptive management paradigm experienced 74% longer median progression-free survival (16.0 months vs. 9.2 months) and a 47% reduction in the risk of deterioration in global health status.
  • The recommended protocol involves repeat Guardant360 CDx testing every three months during therapy to identify emerging ESR1 mutations before clinical or radiographic disease progression.
  • Approximately 37,000 U.S. women currently receiving aromatase inhibitors for advanced HR-positive breast cancer may benefit from this early interception approach.
  • This approval marks the 29th CDx indication for Guardant360 CDx globally, covering more than 300 million lives through Medicare and commercial payer coverage.
  • The approval results from a strategic collaboration between Guardant Health and AstraZeneca to integrate Guardant360 CDx into clinical development for camizestrant.