Tuesday, January 31, 2023
Guardant Health announced today that the U.S. Food and Drug Administration (FDA) has approved its Guardant360® CDx liquid biopsy test as a companion diagnostic to identify advanced or metastatic breast cancer patients with ESR1 mutations who may benefit from treatment with ORSERDU™ (elacestrant), a nonsteroidal selective oestrogen receptor degrader to be commercialised by Stemline Therapeutics, Inc.
Guardant360 CDx is approved as a companion diagnostic to identify patients with non-small cell lung cancer benefitting from treatment with TAGRISSO® (osimertinib), RYBREVANT® (amivantamab-vmjw), ENHERTU® (fam-trastuzumab deruxtecan-nxki) or LUMAKRAS™ (sotorasib). It is also FDA approved to identify advanced breast cancer patients with ESR1 mutations who may benefit from treatment with ORSERDU™ (elacestrant).
FDA approved Guardant360 CDx as a companion diagnostic (CDx) in conjunction with the approval of ORSERDU for postmenopausal women or adult men with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated, advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
Guardant360 CDx blood test provides comprehensive genomic profiling to identify patients with ESR1 mutations benefited from ORSERDU targeted therapy.
ORSERDU (elacestrant) is first FDA-approved endocrine therapy innovation in more than 20 years, addressing ESR1 mutations, a major unmet need.
