- Guardant Health ( NASDAQ: GH ) said that the U.S. Food and Drug Administration (FDA) approved its Guardant360 CDx liquid biopsy test as a companion diagnostic for use with Menarini's medicine Orserdu.
- Guardant360 can be used now to identify patients with advanced or metastatic breast cancer having ESR1 mutations who may benefit from Orserdu (elacestrant).
- The FDA approved test as a companion diagnostic (CDx) in conjunction with the approval of Orserdu for postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated, advanced or metastatic breast cancer with disease progression after at least one line of endocrine therapy.
- The approval as a CDx for Orserdu is the company's fifth FDA approval for the Guardant360 CDx test and its first in breast cancer, according to Guardant.
- Orserdu was granted priority review by the FDA in August 2022.
For further details see:
Guardant's test gets FDA nod for companion diagnostic to breast cancer drug Orserdu