What happened
The FDA accepted Bayer’s supplemental application for elinzanetant, sold in the United States as Lynkuet, and granted priority review. The proposed indication is for moderate to severe hot flashes associated with endocrine therapy in women receiving treatment or preventive therapy for hormone-receptor-positive breast cancer.
Why it matters
Hot flashes can be disruptive during endocrine therapy, while treatment choices may be constrained. The application is based on the Phase III OASIS-4 program, but the FDA has not yet decided whether to approve this additional use.
What to watch
The FDA decision, the final prescribing language, safety findings, interactions with oncology care and whether access extends beyond specialist centres.
