Context Therapeutics (NASDAQ:CNTX) said its clinical trial collaborator Stemline Therapeutics' medicine Orserdu was approved by the U.S. Food and Drug Administration (FDA) to treat a type of breast cancer.
Menarini Group's unit Stemline's drug Orserdu (elacestrant) was approved by the FDA on Jan. 27, to treat postmenopausal women or adult men with estrogen receptor–positive (ER+), HER2-negative (HER2-), Estrogen Receptor 1 gene (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
"This is a watershed moment for the industry, which has spent the last 20 years trying to develop a next-generation endocrine therapy that is pharmacologically superior to endocrine monotherapies, including fulvestrant," said Context's CEO Martin Lehr.
Orserdu is being evaluated in combination with Context's onapristone extended release (ONA-XR) to treat patients with a type of breast cancer in a study called ELONA, Context added.
On Monday, Guardant Health (GH) said Guardant360 CDx liquid biopsy test was approved by the FDA as a companion diagnostic for use with Orserdu.
Orserdu was granted priority review by the FDA in August 2022. The approval was backed by data from a phase 3 trial called EMERALD.
CNTX +74.23% to $1.19 premarket Jan. 31