Bayer Lynkuet granted FDA Priority Review for VMS in women on endocrine therapy for HR+ breast cancer
- FDA accepted Bayer’s supplemental NDA and granted Priority Review for Lynkuet (elinzanetant) for VMS in women receiving endocrine therapy for HR+ breast cancer.
- OASIS-4 was a 52-week, double-blind, randomized placebo-controlled Phase III trial at 90 non-US sites enrolling 474 women aged 18–70, randomized 2:1 (elinzanetant n=316; placebo n=158).
- Lynkuet met primary endpoints with statistically significant reductions in frequency of moderate to severe VMS at weeks 4 and 12 versus placebo; secondary endpoints (severity, week 1 frequency, sleep, menopause-related QoL) were also achieved and effects were maintained.
- Lynkuet is a first-in-class dual NK‑1/NK‑3 receptor antagonist; it was approved in the US in October 2025 for menopausal VMS and in the EU (Nov 2025), UK, Switzerland and Canada for VMS including those caused by adjuvant endocrine therapy.
Regulatory update
The U.S. Food and Drug Administration has accepted Bayer’s supplemental new drug application and granted Priority Review for Lynkuet (elinzanetant) for treatment of moderate to severe vasomotor symptoms (VMS) in women receiving endocrine therapy for hormone receptor–positive (HR+) breast cancer.
Clinical evidence
The Priority Review package is supported by results from the Phase III OASIS-4 trial. OASIS-4 was a 52-week, double-blind, randomized placebo-controlled study conducted at 90 sites outside the US that randomized 474 women aged 18–70 in a 2:1 ratio to elinzanetant (n=316) for 52 weeks or placebo for 12 weeks followed by elinzanetant for 40 weeks (n=158).
Lynkuet met its primary endpoints, showing statistically significant reductions in the frequency of moderate to severe VMS from baseline to weeks 4 and 12 versus placebo. All secondary endpoints were also met, including reductions in VMS severity at weeks 4 and 12, an early frequency reduction at week 1, and improvements in sleep disturbances and menopause-related quality of life, with effects maintained over the study period. Key findings were presented at ASCO 2025 and published in the New England Journal of Medicine in June 2025.
Context and guideline recognition
Elinzanetant is a dual neurokinin (NK‑1 and NK‑3) receptor antagonist developed for oral once-daily treatment of moderate to severe VMS associated with menopause or caused by endocrine therapy. The drug is already approved in the US (October 2025) for menopausal VMS and in the EU (November 2025), UK, Switzerland and Canada for VMS including those caused by adjuvant endocrine therapy. The National Comprehensive Cancer Network’s survivorship guidelines list Lynkuet as a preferred non-hormonal pharmacologic option in the NK‑1 and/or NK‑3 antagonist category for medically or surgically induced menopause.
Source: Bayer