Guardant360 CDx test is said to offer genomic results for oncologists in seven days from a simple blood draw
The FDA has cleared Guardant360 CDx as a companion diagnostic for ORSERDU therapy. (Credit: Guardant Health)
Guardant Health has received approval from the US Food and Drug Administration (FDA) to use its Guardant360 CDx liquid biopsy test as a companion diagnostic (CDx) for Menarini Group’s ORSERDU (elacestrant) for identifying advanced or metastatic breast cancer patients with ESR1 mutations.
The US-based precision oncology company designed the Guardant360 CDx test to offer genomic results for oncologists in seven days from a simple blood draw.
ORSERDU is a nonsteroidal selective estrogen receptor (ER) degrader, which will be marketed by Stemline Therapeutics, a fully-owned subsidiary of Italy-based Menarini Group.
It is claimed as the first treatment to be cleared by the FDA for ESR1-mutated advanced breast cancer patients whose disease has progressed after receiving at least one line of endocrine therapy.
Guardant Health co-CEO Helmy Eltoukhy said: “This FDA approval is great news for breast cancer patients with ESR1 mutations, who now have, for the first time, an approved treatment for their specific type of cancer and a blood-based companion diagnostic.
“We are pleased that the Guardant360 CDx liquid biopsy is now approved so that oncologists and their patients can access comprehensive genomic profiling to see if they are eligible to receive this therapy.”
The FDA approval of Guardant360 CDx is in conjunction with ORSERDU’s approval for the treatment of postmenopausal women or adult men with ER positive, human epidermal growth factor receptor 2 (HER2) negative, ESR1-mutated breast cancer. The approval is for patients with disease progression following at least one line of endocrine therapy.
The Guardant360 CDx test has received its fifth FDA approval overall and its first in a breast cancer indication.
Menarini Group CEO Elcin Barker Ergun said: “We are proud to bring the very first treatment targeting ESR1 mutations which are present in up to 40% of ER+/HER2- advanced breast cancers.
“We’re also pleased with the approval of the Guardant360 CDx blood test as the companion diagnostic to help oncologists identify patients who may benefit from this innovative endocrine therapy.”