Patient groups urge Congress to reauthorize Prescription Drug User Fee Act, improve clinical trial diversity

Positive topline results have come out of the randomized phase II FOURLIGHT-1 study evaluating atirmociclib in combination with fulvestrant, versus fulvestrant or everolimus plus exemestane, in people with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer who had received prior cyclin-dependent kinase 4/6 inhibitor-based treatment. 

The phase III persevERA Breast Cancer study, evaluating investigational giredestrant in combination with palbociclib for people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, did not meet its primary objective of a statistically significant improvement in progression-free survival in the intent-to-treat population versus letrozole plus palbociclib, but a numerical improvement was observed.