MHRA authorises Lynkuet for hot flushes linked to breast cancer therapy
pharmafile | August 21, 2026 | News story | |Â Â MHRA, breast cancer therapy, hot flushesÂ
The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised an extension to the indication for Lynkuet (elinzanetant), allowing its use to treat moderate to severe hot flushes caused by adjuvant endocrine therapy for breast cancer.
Elinzanetant is a hormone-free treatment that targets neurokinin-1 and neurokinin-3 receptors. According to Bayer, it is the first treatment authorised in the UK specifically for vasomotor symptoms associated with endocrine therapy in this patient group.
Hot flushes and other vasomotor symptoms can be a persistent and disruptive side effect for women receiving endocrine therapy following hormone-receptor-positive breast cancer. Symptoms can affect sleep, daily activities and quality of life, and may also make it more difficult for some patients to continue treatment.
Dr Paula Briggs, consultant in sexual and reproductive health at Liverpool Women’s NHS Foundation Trust and immediate past chair of the British Menopause Society, said the authorisation provided a new evidence-based, hormone-free option for an area of significant unmet need.
The MHRA decision was based on results from the phase 3 OASIS-4 study, which evaluated elinzanetant in women with, or at high risk of developing, hormone-receptor-positive breast cancer experiencing vasomotor symptoms caused by adjuvant endocrine therapy.
The study found statistically significant reductions in the daily frequency of moderate to severe symptoms compared with placebo at both four and 12 weeks. Improvements were also reported in sleep disturbance and menopause-related quality of life.
Lynkuet was first authorised in the UK in July 2025 for moderate to severe vasomotor symptoms associated with menopause. The new indication extends its potential use to women experiencing similar symptoms as a consequence of breast cancer treatment.
Dr Joep Hufman, country medical director at Bayer UK & Ireland, said the extension gave healthcare professionals an additional evidence-based option to consider when supporting women experiencing treatment-related symptoms.
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