Canada expands use of non-hormonal hot flash treatment for breast cancer patients
Latest news on WhatsApp أجدد الأخبار على واتساب
Bayer announced on August 17, 2026, that Health Canada issued a Notice of Compliance expanding the indication for Lynkuet (elinzanetant) to include the treatment of moderate to severe hot flashes and night sweats caused by adjuvant endocrine therapy related to breast cancer, after a Phase III clinical trial involving 474 women found that the non-hormonal treatment reduced these symptoms more than placebo.
The expanded indication was supported by results from the OASIS-4 trial, which evaluated the drug in women aged 18 to 70 who experienced moderate to severe vasomotor symptoms while receiving endocrine therapy for hormone receptor-positive breast cancer, or for prevention in women at high risk. A total of 316 participants received elinzanetant, while 158 received placebo during the first 12 weeks.
The results showed that after four weeks, the average number of daily episodes fell by 6.5 in the elinzanetant group, compared with 3 episodes in the placebo group. By week 12, the reduction reached 7.8 episodes per day in the treatment group, compared with 4.2 in the placebo group, a statistically significant difference.
Elinzanetant works without hormones and targets neurokinin receptors involved in the body's temperature regulation. This is particularly relevant for breast cancer patients who develop hot flashes and night sweats while receiving adjuvant endocrine therapy.
During the first 12 weeks, adverse events were reported in 69.8% of participants receiving elinzanetant, compared with 62% in the placebo group. Headache, fatigue and sleepiness were among the most commonly reported events, while serious adverse events occurred in 2.5% of the treatment group and 0.6% of the placebo group.
The OASIS-4 study was published in the New England Journal of Medicine in June 2025. The study states that it was funded by Bayer, the manufacturer of the drug, an important disclosure when assessing the evidence supporting the expanded indication in Canada.
Health Canada's Drug Product Database lists Lynkuet as a prescription medicine marketed in Canada, with each capsule containing 60 mg of elinzanetant. The updated product monograph is dated August 12, 2026.
