Context Therapeutics’ Clinical Partner Stemline Therapeutics Receives the US FDA’s Approval of Orserdu (elacestrant) for ER+, HER2-, ESR1-Mutated Breast Cancer
Shots:
- The US FDA has approved Orserdu for postmenopausal women or adult men with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer. The approval was based on the P-III trial (EMERALD) results evaluating elacestrant vs SoC endocrine monotx. in 478 patients
- The trial met both 1EPs in all patients & whose tumors harbor ESR1 mutations (45% reduction in risk of progression or death) along with a significant PFS, m-PFS (8.6 vs 1.9mos.) whose tumors harbored ESR1 mutations & had been treated with a CDK4/6i for 12mos.
- ONA-XR (onapristone extended release), an oral progesterone receptor antagonist is being tested in the ongoing P-Ib/II trial (ELONA) to improve the activity of Orserdu in ESR1-mutated & wild-type metastatic breast cancer
Ref: GlobeNewswire | Image: Context Therapeutics
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