FDA Approves Orserdu Liquid Biopsy Companion Diagnostic

Guardant Health’s Guardant360 CDx liquid biopsy test has been approved by the FDA as a companion diagnostic to identify advanced or metastatic breast cancer patients with ESR1 mutations who may benefit from treatment with Stemline Therapeutics’ Orserdu (elacestrant), a nonsteroidal selective estrogen receptor degrader.

The blood test provides comprehensive genomic profiling to identify the approximately 40 percent of ER+/HER2- advanced breast cancers with ESR1 mutations.

Orserdu was recently FDA approved as a first treatment for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer who have experienced disease progression after at least one line of endocrine therapy.

Stemline Therapeutics, headquartered in the U.S., a wholly-owned subsidiary of Menarini Group, headquartered in Italy is marketing Orserdu (elacestrant) and Guardant Health is marketing the companion diagnostic Guardant360 CDx test.