FDA grants Priority Review to Bayer’s elinzanetant for moderate to severe vasomotor symptoms in women receiving endocrine therapy for HR-positive breast cancer.
Written By: Creola Gonsalves, MS Biotech
Reviewed By: Pharmacally Editorial Team
Bayer’s supplemental new drug application for Lynkuet™ (elinzanetant) has received U.S. FDA Priority Review for moderate to severe vasomotor symptoms associated with endocrine therapy for hormone receptor-positive breast cancer. The submission is supported by Phase III OASIS-4 (NCT05587296) data showing significant reductions in hot-flash frequency and improvements in sleep and menopause-related quality of life.
FDA Review Expands Elinzanetant’s Potential Use
The U.S. FDA has accepted Bayer’s sNDA for elinzanetant in women receiving endocrine therapy for the treatment or prevention of HR-positive breast cancer. Priority Review shortens the FDA’s standard review target when the agency determines that an application may provide a significant improvement in safety or effectiveness compared with available options.
Elinzanetant was approved in the U.S. in October 2025 for moderate to severe vasomotor symptoms associated with menopause. The oral, once-daily therapy is also approved in the European Union, UK, Switzerland and Canada for VMS associated with menopause or caused by adjuvant endocrine therapy for breast cancer.
The regulatory expansion is based on results from the Phase III OASIS-4 trial.
OASIS-4 Showed Significant VMS Reduction
OASIS-4 was a 52-week, double-blind, randomized, placebo-controlled Phase III study conducted at 90 sites outside the U.S. It enrolled 474 women aged 18 to 70 years who experienced moderate to severe VMS while receiving endocrine therapy for HR-positive breast cancer or for breast cancer prevention.
Participants were randomized 2:1 to elinzanetant 60 mg once daily (n=316) for 52 weeks or placebo (n=158) for 12 weeks followed by elinzanetant for 40 weeks.
The study met both primary endpoints, demonstrating statistically significant reductions in the frequency of moderate to severe VMS at weeks 4 and 12 compared with placebo.
Elinzanetant also met all reported secondary endpoints. Treatment reduced VMS severity at weeks 4 and 12 and reduced VMS frequency as early as week 1. Patients also reported improvements in sleep disturbances and menopause-related quality of life at week 12, with benefits maintained during the longer treatment period.
The OASIS-4 results were presented at ASCO 2025 and published simultaneously in the New England Journal of Medicine in June 2025.
Dual Neurokinin Targeting
Elinzanetant is a dual neurokinin receptor antagonist that blocks both NK-1 and NK-3 receptors. These pathways are involved in the activity of hypothalamic KNDy neurons, which regulate body temperature.
Reduced estrogen activity during natural menopause or endocrine therapy can increase KNDy neuron activity and disrupt thermoregulation, contributing to hot flashes. By targeting NK-1 and NK-3 signaling, elinzanetant addresses this neuroendocrine pathway without using estrogen-based hormone therapy.
This distinction is clinically relevant for many women with HR-positive breast cancer, for whom endocrine therapy remains an important component of treatment but can produce disruptive menopausal symptoms.
Implications for Breast Cancer Care
Adjuvant endocrine therapy can continue for several years and substantially reduce recurrence and mortality risk in HR-positive breast cancer. However, treatment-associated VMS can impair quality of life and may contribute to difficulties with long-term treatment adherence.
“It’s important that we continue to learn more about vasomotor symptoms due to endocrine therapy as part of supporting women throughout their breast cancer care journey,” said Fatima Cardoso, MD, the OASIS-4 primary investigator.
The U.S. submission follows regulatory expansions in the UK, Switzerland and Canada, while the European Union already permits use for VMS caused by adjuvant endocrine therapy.
Next Regulatory Milestone
The FDA’s Priority Review marks the next regulatory step for elinzanetant in breast cancer-associated VMS. Bayer is also pursuing regulatory submissions in additional countries.
If approved in the U.S. for this population, the indication would expand elinzanetant beyond menopause-associated VMS to women experiencing treatment-induced vasomotor symptoms during HR-positive breast cancer care.
Reference
Bayer’s Lynkuet™ (elinzanetant) granted priority review by U.S. FDA for additional indication, Bayer, 28 September 2026
A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer (OASIS-4), ClinicalTrials.gov ID NCT05587296
About the Writer
Creola Gonsalves (Linkedin) is an M.S. Biotechnology postgraduate with a strong interest in clinical research, evidence interpretation, and healthcare writing, with a focus on translating life-science knowledge into meaningful real-world insights.
She is trained in Good Clinical Practice (GCP), clinical research principles, and critical interpretation of randomized clinical trials, with certifications from NIH and Stanford University.
Her research background in biotechnological applications and microbial research strengthens her ability to understand scientific evidence and develop clear, accurate, and research-driven healthcare content.