Health Canada Approves Elinzanetant for Hot Flashes in Breast Cancer Patients

A new non-hormonal treatment option may help breast cancer patients experiencing moderate to severe hot flashes and night sweats caused by endocrine therapy.

For many women being treated for hormone-receptor-positive breast cancer, managing the cancer can come with another difficult challenge: hot flashes, night sweats, and other menopausal symptoms.

Health Canada has now authorized elinzanetant, marketed as Lynkuet, for the treatment of moderate to severe vasomotor symptoms associated with endocrine therapy for breast cancer.

Elinzanetant had previously been authorized for menopausal vasomotor symptoms. The expanded authorization follows evidence from the Phase III OASIS-4 study evaluating women receiving endocrine therapy for breast cancer. Bayer reported that the study demonstrated significant reductions in the frequency and severity of hot flashes, as well as improvements in sleep disturbances and menopause-related quality of life.

Why Can Breast Cancer Treatment Cause Hot Flashes?

Many breast cancers are hormone-receptor positive, meaning that hormones such as estrogen can help the cancer grow. One important part of treatment is therefore to reduce estrogen activity in the body. Endocrine therapies, including medications such as tamoxifen and aromatase inhibitors, can produce a state of reduced estrogen activity that resembles menopause.

For some patients, the resulting symptoms can be significant: frequent hot flashes, night sweats, sleep disruption, difficulty concentrating, reduced quality of life, and daytime fatigue. These symptoms are not simply an inconvenience. In some patients, they can make it harder to tolerate an otherwise important cancer treatment.

Why Is a Non-Hormonal Treatment Important?

Hormone replacement therapy is commonly used to manage menopausal symptoms in some patients. However, systemic hormone therapy is generally not an appropriate option for many women with hormone-sensitive breast cancer. That has created a particular need for non-hormonal approaches to managing vasomotor symptoms in breast cancer patients.

Elinzanetant works differently from hormone replacement therapy. It is a dual neurokinin-1 and neurokinin-3 receptor antagonist. Rather than replacing estrogen, it targets neural pathways involved in the body’s temperature regulation.

What Did the OASIS-4 Study Find?

The Phase III OASIS-4 trial studied women experiencing moderate to severe vasomotor symptoms while receiving endocrine therapy for hormone-receptor-positive breast cancer.

Compared with placebo, elinzanetant produced statistically significant reductions in the frequency of vasomotor symptoms at both four and 12 weeks. The study also reported improvements in severity of hot flashes, sleep disturbances, and menopause-related quality of life. The treatment was evaluated over a 52-week period, with the reported safety profile generally consistent with previous studies of elinzanetant.

Importantly, clinical-trial results do not mean that every patient will experience the same degree of benefit. Treatment decisions should be individualized.

What Does This Mean for Patients?

The authorization provides another potential treatment option for breast cancer patients whose hot flashes and night sweats are related to endocrine therapy. However, elinzanetant is not a replacement for breast cancer treatment. Patients should not stop or change tamoxifen, an aromatase inhibitor, or another cancer treatment because of menopausal symptoms without speaking with their oncology team.

Instead, persistent or severe symptoms should be discussed with the healthcare professionals involved in the patient’s care.

The Pharmacist’s Role Matters

At Centrum Pharmacy, medication counselling involves more than simply dispensing a prescription. When a patient is considering a medication for menopausal symptoms, particularly while taking cancer therapy, the pharmacist can help review the complete medication profile and identify potential medication-related concerns. This may include reviewing prescription and non-prescription medications, checking for potential drug interactions, discussing how the medication is intended to be taken, reviewing expected benefits and possible adverse effects, helping patients understand when they should contact their physician or oncology team, and coordinating with the patient’s healthcare providers when clarification is required.

Cancer patients may be taking several medications at the same time, making a comprehensive medication review particularly important.

A Reminder About Supplements and “Natural” Menopause Products

Patients experiencing hot flashes sometimes turn to over-the-counter supplements or herbal products. “Natural” does not automatically mean safe or appropriate, particularly for someone receiving cancer treatment. Some supplements can interact with prescription medications or potentially affect how medicines are metabolized. Patients should tell their pharmacist and oncology team about all supplements and natural health products they use or are considering.

Could This Medication Be Right for You?

That depends on the individual patient. A new Health Canada authorization does not mean that every person experiencing hot flashes should take elinzanetant. Eligibility, current cancer treatment, other medications, medical history, potential interactions, and individual risks and benefits all need to be considered.

If you are undergoing breast cancer treatment and troublesome hot flashes or night sweats are affecting your sleep or quality of life, speak with your oncologist, physician, or pharmacist about your options. At Centrum Pharmacy, our pharmacists can help you understand your medications and work with your healthcare team to support safe, coordinated care.

Disclaimer: The medical information on this site is provided as an information resource only and is not to be used or relied on for any diagnostic or treatment purposes. This information does not substitute for professional diagnosis and treatment. Please do not initiate, modify, or discontinue any treatment, medication, or supplement solely based on this information. Always seek the advice of your healthcare provider first. Full Disclaimer.