On September 28, 2026, the FDA accepted and granted priority review to a Supplemental New Drug Application for elinzanetant (Lynkuet; Bayer) to treat vasomotor symptoms (VMS) in women using endocrine therapy to treat or prevent hormone receptor-positive (HR+) breast cancer, according to an announcement from Bayer.¹

Additionally, elinzanetant has become the first therapy indicated to treat moderate-to-severe VMS because of adjuvant endocrine therapy (AET) for breast cancer in Canada, the United Kingdom, and Switzerland, in addition to the initial indication for VMS associated with menopause.

That indication was first approved in the United States in October 2025 based on data from three phase 3 trials (OASIS-1, OASIS-2, and OASIS-3).²

“Endocrine therapy is a standard of care for many women facing HR+ breast cancer, which can commonly cause side effects such as vasomotor symptoms,” said OASIS-4 Primary Investigator Fatima Cardoso, MD, FESMO Director, Breast Unit, Centre Antoine Lacassagne and Advanced Breast Cancer (ABC) Global Alliance, Nice, France, in a statement.

“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.”

What did the OASIS-4 trial show?

The sNDA is based on results from the Phase III OASIS-4 trial, the key findings of which were presented at ASCO 2025 and simultaneously published in the New England Journal of Medicine in June 2025. The study was a 52-week, double-blind, randomized, placebo-controlled interventional trial conducted at 90 sites outside the US. A total of 474 women aged 18 to 70 years with moderate to severe VMS caused by AET for HR+ breast cancer or its prevention were randomized 2:1 to elinzanetant (n = 316) for 52 weeks or placebo for 12 weeks, followed by elinzanetant for 40 weeks (n = 158).

Elinzanetant met the primary endpoints, demonstrating statistically significant reductions in the frequency of moderate to severe VMS from baseline to week 4 and 12 compared with placebo.

All secondary endpoints were also achieved, including reductions in VMS severity at weeks 4 and 12, VMS frequency reduction at week 1, and improvements in sleep disturbances and menopause-related quality of life from baseline to week 12 vs. placebo, with effects maintained over the study period.

RELATED: How patients are responding to elinzanetant, with Genevieve Neal-Perry, MD, PhD

In the discussion at the link above from ACOG's 75th Annual Meeting, Genevieve Neal-Perry, MD, PhD, explains how elinzanetant has impacted patients since its approval in October 2025.³

Reference:

1. Bayer’s Lynkuet (elinzanetant) granted priority review by US FDA for additional indication. Bayer. Published September 28, 2026. Accessed September 28, 2026. https://www.bayer.com/media/en-us/bayers-lynkuet-elinzanetant-granted-priority-review-by-us-fda-for-additional-indication/
2. FDA approves elinzanetant (Lynkuet) for vasomotor menopausal symptoms. Contemporary OB/GYN. Published October 24, 2025. Accessed September 28, 2026. https://www.contemporaryobgyn.net/view/fda-approves-elinzanetant-lynkuet-for-vasomotor-menopausal-symptoms
3. How patients are responding to elinzanetant, with Genevieve Neal-Perry, MD, PhD. Contemporary OB/GYN. Published May 1, 2026. Accessed September 28, 2026. https://www.contemporaryobgyn.net/view/how-patients-are-responding-to-elinzanetant-with-genevieve-neal-perry-md-phd