For many women being treated for hormone receptor-positive breast cancer, the cancer treatment itself can trigger another difficult problem: severe hot flushes and night sweats. And unlike many other women going through menopause, these women may not be good candidates for traditional hormone replacement therapy.
That is why a new FDA development is worth watching.
On September 28, 2026, the FDA accepted a supplemental application from Bayer and granted Priority Review to Lynkuet (elinzanetant) for the treatment of moderate-to-severe hot flushes caused by endocrine therapy used to treat or help prevent hormone receptor-positive breast cancer. (Bayer Global)
What is Lynkuet?
Lynkuet is a non-hormonal prescription medication that works by blocking two receptors in the brain—NK-1 and NK-3—that are involved in regulating body temperature. The medication is not brand new. The FDA originally approved Lynkuet in October 2025 for moderate-to-severe hot flushes caused by menopause. (U.S. Food and Drug Administration) What is new is the possibility of expanding its use to women experiencing hot flushes as a side effect of breast-cancer endocrine therapy.
That distinction is important.
Why this could matter
Endocrine therapy is commonly used in women with hormone receptor-positive breast cancer. These medications are designed to reduce estrogen activity, but they can also cause significant menopause-like symptoms. Hot flushes, sleep disruption and night sweats can become more than an inconvenience. For some women, they can interfere with quality of life and even make it harder to stay on long-term cancer treatment.
The Phase III OASIS-4 study included 474 women receiving endocrine therapy for the treatment or prevention of hormone receptor-positive breast cancer. Women taking elinzanetant experienced significantly greater reductions in hot-flush frequency than women taking placebo at both four and 12 weeks. The study also reported improvements in sleep disturbances and menopause-related quality of life. (PubMed)
That is encouraging news, but there is an important distinction here:
The FDA has not yet approved Lynkuet for this specific use.
Priority Review means the FDA considers the application important enough to review on an expedited timetable. It does not guarantee approval.
What about side effects?
Like any medication, Lynkuet is not risk-free. In the OASIS-4 trial, common side effects included headache, fatigue and sleepiness. Diarrhea was also reported more often with elinzanetant during the placebo-controlled portion of the study. (Bayer Global). Women considering this medication should also review their complete medical history and other medications with their healthcare provider.
The bigger picture
This development is another example of how quickly menopause medicine is changing. For years, many women who could not use hormone therapy were left feeling as though their options were extremely limited. That is no longer necessarily true.
Non-hormonal medications such as Lynkuet are expanding the conversation—and potentially giving women more choices.
I’ll continue watching the FDA’s review of Lynkuet and will update you if this new indication is approved.
This information is for educational purposes only and is not a substitute for medical advice from your healthcare provider.