Health Canada has authorised the use of elinzanetant — marketed as Lynkuet — for the treatment of moderate to severe hot flashes and night sweats in women with breast cancer who are experiencing these vasomotor symptoms while on anti‑oestrogen therapy. The new indication took effect on Friday, according to the federal regulator’s drug database.
Non‑hormonal option for those who cannot use HRT
About two‑thirds of breast cancers are hormone‑receptor positive, meaning tumour growth is fuelled by oestrogen. Standard treatment often involves drugs that suppress or block the body’s production or action of oestrogen — commonly tamoxifen or aromatase inhibitors — and these treatments can trigger intense hot flashes and night sweats.
Because hormone replacement therapy (HRT) is generally contraindicated for many women with oestrogen‑sensitive breast cancer, options to relieve vasomotor symptoms have been limited. Elinzanetant is a non‑hormonal medicine that acts on specific neurons implicated in hot flashes, offering a mechanistic alternative to HRT.
Clinical evidence and expert perspective
Elinzanetant was previously authorised in July 2025 for treatment of menopausal vasomotor symptoms more broadly. Health Canada reviewed an additional study that focused specifically on women with breast cancer taking anti‑oestrogen therapy and found evidence supporting benefit in that population, prompting the expanded market authorisation.
“The clinical trial with elinzanetant was the very first one that actually looked at breast cancer patients on anti‑estrogen therapy,”
said Dr. Christine Brezden‑Masley, medical director of the cancer programme at Sinai Health in Toronto. Dr. Brezden‑Masley noted breast cancer survivors have faced a paucity of effective, safe treatments for vasomotor symptoms because many standard menopause therapies are not suitable.
Why this matters
Vasomotor symptoms can substantially disrupt daily life: daytime functioning may be impaired by sudden sensations of intense heat and sweating, while night sweats frequently fragment sleep. Poor sleep and persistent symptoms can affect quality of life and may even influence adherence to long‑term endocrine therapies, which are typically prescribed for about five to 10 years.
The approval provides clinicians with an additional tool to manage these often debilitating side effects without exposing patients to oestrogenic therapies that could be harmful for hormone‑sensitive disease.
Key details at a glance
- Drug: elinzanetant (brand name Lynkuet)
- Indication: moderate to severe hot flashes and night sweats in women with breast cancer on anti‑oestrogen therapy
- Type of therapy: non‑hormonal agent targeting neurons involved in vasomotor regulation
- Previous approval: July 2025 for menopausal vasomotor symptoms
| Fact | Detail |
|---|---|
| Proportion of breast cancers that are hormone‑receptor positive | About two‑thirds |
| Typical duration of endocrine therapy | 5–10 years |
Clinical and access considerations
Oncologists will weigh the benefits of symptom reduction against safety and cost considerations when recommending elinzanetant. The federal authorisation makes the treatment available for clinicians to prescribe in Canada, but access will also depend on provincial formularies, private insurance coverage and individual clinical judgment.
Further real‑world experience and post‑marketing surveillance will help clarify how broadly the drug is used and whether certain subgroups derive greater benefit. Health care teams will also need to counsel patients on expected effects and monitor outcomes as part of usual cancer survivorship care.
For many women with oestrogen‑sensitive breast cancer, the availability of a targeted, non‑hormonal treatment for vasomotor symptoms represents an important advance in supportive care that may improve comfort and help sustain adherence to life‑saving endocrine therapy.
