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Based on data from the phase III SOLAR-1 trial, alpelisib (Piqray) has been approved by the FDA for the treatment of postmenopausal women, and men, with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.

Findings from ongoing immunotherapy studies are expected to change the treatment paradigm in breast cancer as these agents become available to larger subsets of patients, according to Hope S. Rugo, MD, and Elizabeth A. Mittendorf, MD, PhD, who presented data at the 36th Annual Miami Breast Cancer Conference® hosted by Physicians’ Education Resource®, LLC.