Guardant Health Receives the US FDA’s Approval of Guardant360 CDx Liquid Biopsy Test for Breast Cancer
- The US FDA has approved Guardant360 CDx liquid biopsy test for patients with advanced or metastatic breast cancer patients harboring ESR1 mutations who may derive benefit from treatment with Orserdu (elacestrant)
- The approval was based on the results from the P-III trial (EMERALD) evaluating Elacestrant as monotx. vs SoC in 466 patients with ER+/HER2- advanced breast cancer
- The trial met its co-primary EPs of PFS & the results showed a 30% reduction in risk of progression or death at a median follow-up of 15.5mos., m-PFS was 3.8 vs 1.9mos., 45% reduction in the risk of progression for patients with a confirmed ESR1 mutation & the safety results was consistent with the other endocrine therapies with no hematological safety signal
Ref: Businesswire | Image: Guardant Health
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