Guardant Health has secured approval from the US Food and Drug Administration (FDA) to use its Guardant360CDx liquid biopsy test as a companion diagnostic (CDx) for ORSERDU (elacestrant).
The test can now be used as a CDx for the detection of advanced or metastatic breast cancer patients with ESR1 mutations who are expected to benefit from treatment with ORSERDU.
ORSERDU is a nonsteroidal selective estrogen receptor degrader, which will be launched into the market by Menarini Group’s wholly-owned subsidiary Stemline Therapeutics.
Guardant360 CDx has been approved as a CDx at the same time as ORSERDU has been approved 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 progressed disease after a minimum of one line of endocrine therapy.
The latest development is said to be Guardant Health’s fifth FDA approval for the test as well as its first for breast cancer.
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 CDx.
“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.”
Claimed to be the first FDA-approved blood test for complete genomic testing, the Guardant360 CDx test offers comprehensive genomic results from a simple blood draw in seven days.
The test covers all genes suggested by the National Comprehensive Cancer Network.