FDA grants Priority Review to Bayer's Lynkuet for breast cancer

The US Food and Drug Administration (FDA) has accepted Bayer's supplemental New Drug Application (sNDA) and granted Priority Review for Lynkuet (elinzanetant). The regulatory review covers a proposed new indication to treat moderate to severe vasomotor symptoms, commonly known as hot flashes, in women undergoing endocrine therapy for breast cancer.

Lynkuet 60mg capsules was first approved by the FDA in October 2025 to treat moderate to severe menopausal hot flashes. The drug is a dual neurokinin 1 (NK-1) and neurokinin 3 (NK-3) receptor antagonist. Kristie Baisden, DO, Vice President, U.S. Medical Affairs, Women's Health at Bayer, noted that no FDA-approved options currently exist in the US for moderate to severe vasomotor symptoms linked to endocrine therapy in HR+ breast cancer patients.

The sNDA submission is supported by findings from the 52-week Phase III OASIS-4 clinical trial, conducted at 90 sites outside the United States across 474 women aged 18 to 70. Participants were randomized 2:1 to receive elinzanetant (316 patients) for 52 weeks or placebo (158 patients) for 12 weeks followed by 40 weeks of elinzanetant. The trial met its primary endpoints by reducing the mean daily frequency of symptoms from baseline to weeks 4 and 12 compared with placebo. Common adverse events included headache, fatigue, and somnolence.

Breast cancer represents 30% of all cancers diagnosed in American women, and HR+ cases make up roughly 70% of those diagnoses. Standard guidelines from the American Society of Clinical Oncology recommend endocrine therapy for a minimum of 5 years, with potential extensions up to 10 years.