Bayer said the U.S. Food and Drug Administration (FDA) granted Priority Review to a supplemental New Drug Application for Lynkuet® (elinzanetant). The application seeks approval to treat moderate to severe vasomotor symptoms, or hot flashes, in women undergoing endocrine therapy for breast cancer.
Priority Review is intended to focus attention and resources on evaluating drugs that, if approved, could significantly improve the safety or effectiveness of treatment for serious conditions. There are currently no FDA-approved treatments for this specific condition in patients with hormone receptor-positive (HR+) breast cancer in the United States, leaving a significant unmet medical need.
The application is supported by data from the Phase III OASIS-4 study. Lynkuet, a dual neurokinin receptor antagonist, was first approved by the FDA in October 2025 to treat menopause-related hot flashes.