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According to the latest Annual Report to the Nation on the Status of Cancer, cancer death rates have declined in men, women, and children across all cancer types, and have continued to decline between 1999 and 2016. In a special section of this year’s report, however, data show that both cancer incidence and death rates were higher in women aged 20 to 49 compared to male counterparts.

A look back at all the FDA news that happened in the month of May 2019, including several new approvals, orphan drug designations, breakthrough therapy designations, fast track designations, and more.

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.