Clinical Roundup

RWE and phase I data support the role of Orserdu for ER+, HER2- advanced or metastatic breast 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.
Drugs & Targets

FDA approves new alternative standard related to mammography report assessments

FDA recently approved Alternative Standard #25 related to the Mammography Quality Standards Act. Alternative Standard #25 allows the interpreting physician to provide an assessment of “Incomplete: Need additional imaging evaluation” for the follow-up report issued within 30 calendar days of an initial report that received an assessment of “Incomplete: Need prior mammograms for comparison.”