Flatiron Health and FDA’s Oncology Center of Excellence renewed their collaboration to jointly develop and implement specific research projects to advance the use of real-world data and explore the potential strengths and limitations of using real-world evidence for regulatory purposes. The partnership will specifically evaluate RWD study designs and analytic methods through the collaborative development of priority, clinically meaningful research questions regarding care, treatment, and outcomes of patients with cancer.
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.
