Astellas Pharma has recently announced dosing of the first patient in the HIGHLIGHT 1 Phase 3 pivotal study for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) in women with breast cancer receiving adjuvant endocrine therapy. Breast cancer is the most common cancer in women globally, with approximately 2.3 million new cases in 2022.

Hot flashes and night sweats, also known as VMS, are recognized as the most prominent side effect of adjuvant endocrine therapies used in the treatment of breast cancer. Approximately 77 per cent of breast cancers can be treated with adjuvant endocrine therapies, most commonly tamoxifen and aromatase inhibitors, and up to 97 per cent of breast cancer patients experience hot flashes or night sweats. Marci English, Vice President, Head of BioPharma Development, Astellas said; “VMS can adversely affect quality of life, as well as compliance with treatment, for patients with breast cancer taking adjuvant endocrine therapy. We are excited to get the HIGHLIGHT 1 study underway, as currently there are no approved treatments for moderate to severe VMS that can be used by these patients.”