FDA has issued a draft guidance that describes the types of real world data and real world evidence that the agency would accept as part of regulatory submissions for drugs and biologics.
The Menarini Group and Stemline Therapeutics will present new and expanded data on Orserdu at the upcoming 2024 San Antonio Breast Cancer Symposium, held from Dec. 10-13. The company will bring real-world progression-free survival results of Orserdu in adult patients with ER+/HER2-, advanced or metastatic breast cancer. Additionally, the company will present updated efficacy results of elacestrant plus abemaciclib, along with a pooled safety analysis from phase Ib/2 of both the ELECTRA and ELEVATE trials.
