Company Announcements

Expanded authorization introduces a treatment option for women experiencing moderate to severe hot flashes and/or night sweats caused by adjuvant endocrine therapy (AET) related to breast cancer

• LYNKUET^® is the first NK-1 and NK-3 receptor antagonist indicated in the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause
• Expanded indication is supported by the OASIS-4 study, which evaluated treatment in women with moderate to severe VMS caused by adjuvant endocrine therapy for breast cancer¹

MISSISSAUGA, Ontario--(BUSINESS WIRE)--Aug. 17, 2026-- Bayer Inc. announced today that Health Canada has issued a Notice of Compliance (NOC) expanding the indication of LYNKUET^® (elinzanetant) to include the treatment of moderate to severe vasomotor symptoms (VMS) caused by adjuvant endocrine therapy (AET) related to breast cancer.

With today’s authorization, LYNKUET^® becomes the first approved treatment option in Canada for this patient population. This authorization builds on Health Canada'sJuly 2025 market authorization of LYNKUET^® for the treatment of moderate to severe VMS associated with menopause.¹

“For women receiving endocrine therapy for breast cancer, hot flashes, night sweats and sleep disruption can have a profound impact on daily life and treatment experience. This market authorization introduces a new treatment option designed to address moderate to severe vasomotor symptoms (also known as hot flashes and night sweats) in a population with limited therapeutic alternatives,” says Viktoria Friedrich, Country President and General Manager for the Pharmaceuticals division in Canada.

In a recent Canadian study, moderate to severe VMS were associated with a 30.2% impairment in work productivity and a 35.7% impairment in daily activities.²

About Vasomotor Symptoms in Women Receiving Adjuvant Endocrine Therapy
Breast cancer is the most commonly diagnosed cancer among women in Canada, with approximately 1 in 8 of women expected to develop it during their lifetime.³ For patients with hormone receptor-positive (HR+) breast cancer, endocrine therapy – such as tamoxifen and aromatase inhibitors – is the standard of care.⁴

While endocrine therapy reduces rates of recurrence, it may also cause side effects such as hot flashes, night sweats and sleep disruption that can affect quality of life.⁵ Menopause hormone therapy for VMS is not recommended for women with a history of HR+ breast cancer, making effective non-hormonal options an important clinical need.^4,5

Recent Canadian research found that moderate to severe VMS significantly affected quality of life, sleep, work productivity and daily activities among affected women.²

About the OASIS-4 Study
The Phase III OASIS-4 trial evaluated the safety and efficacy of elinzanetant in women receiving adjuvant endocrine therapy who experienced moderate to severe VMS.⁶

It is part of the broader OASIS clinical development program investigating elinzanetant in women affected by VMS, which also includes OASIS-1, OASIS-2 and OASIS-3 in postmenopausal women.^6,7,8

Across the OASIS program, elinzanetant demonstrated significant reductions in the frequency of VMS compared to placebo and a safety profile that was similar to that of placebo.^6,7,8

About LYNKUET^®
LYNKUET^® is a once-daily oral treatment and the first dual neurokinin-targeted therapy, acting as a selective antagonist of both the neurokinin-1 (NK-1) and neurokinin-3 (NK-3) receptors.¹

It acts by blocking NK-1 and NK-3 receptor signalling on KNDy neurons, which are hyperactivated due to estrogen decline during menopause or treatment with endocrine therapy, thereby modulating neuronal activity involved in thermoregulation.¹

In Canada, LYNKUET^® is now indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause and for the treatment of moderate to severe VMS caused by adjuvant endocrine therapy (AET) related to breast cancer.¹

Community Perspectives
Perspectives from Canada’s health community following today’s announcement:

“When we talk about treating breast cancer, we need to ensure patients are supported through treatment. Adjuvant endocrine therapy is one of our most powerful tools for helping prevent recurrence, but it can leave women managing severe hot flashes that negatively affect quality of life and, too often, lead them to stop the very therapy that protects them. For a long time, our options were limited, especially because hormone-based relief is not appropriate for many breast cancer patients. The introduction of LYNKUET^® in Canada is a meaningful step forward. As a hormone-free treatment, it gives us a new, non-hormonal way to treat these ongoing symptoms and help women stay on therapy.” – Dr. Christine Brezen-Masley, Medical Oncologist and Director of the Marvelle Koffler Breast Centre at Mount Sinai Hospital, and Medical Director of the Cancer Program for Sinai Health System in Toronto, Canada.

“Breast cancer care can't be done in isolation. We must also address the lasting effects of treatment that shape a person's quality of life. For too long, medically induced menopause symptoms like hot flashes and night sweats have been an overlooked consequence of breast cancer care. The availability of a new non-hormonal treatment reflects the progress that is possible when research drives innovation beyond the cancer itself. It is another step toward a more personalized, evidence-based approach, where survivorship and supportive therapies are recognized as essential components of modern breast cancer care.” – Kimberly Carson, CEO, Breast Cancer Canada

“Vasomotor symptoms can have a significant impact on quality of life for people living with breast cancer. For many individuals receiving adjuvant endocrine therapy, symptoms such as hot flashes and night sweats can affect daily functioning and overall wellbeing. The availability of a new treatment option is a welcome step forward in addressing a longstanding gap in care for the breast cancer community.” – Cathy Ammendolea, Chair of the Board of the Canadian Breast Cancer Network

“At Rethink, we regularly hear from people on endocrine therapy about how hot flashes, night sweats and disrupted sleep impact their day to day lives. These symptoms aren’t just uncomfortable, they can affect adherence to treatment, mental health, and overall well-being at an already challenging time. What’s particularly significant is that the evidence behind elinzanetant examines it’s use and impact in people with breast cancer, not simply adapted from another population. That kind of disease specific focus is important, and we’re encouraged to see it reflected here.” – MJ DeCoteau, Founder & Executive Director, Rethink Breast Cancer

About Women’s Health at Bayer
Bayer is committed to delivering Health for All by advancing a portfolio of innovative treatments in women's health. Bayer offers a wide range of contraceptive options, therapies for menopause management and gynecological conditions, and continues to invest in research and development to address unmet needs across women's health including menopause, endometriosis and oncology-related quality-of-life care.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conformthem to future events or developments.

References:

1. Bayer Inc. Lynkuet^® (elinzanetant) Product Monograph. August 12, 2026. Available at: www.bayer.ca
2. Yuksel N, Todorova L, Scrine L, Rea C, Bouchard C. Prevalence and impact of vasomotor symptoms due to menopause among women in Canada: A subgroup analysis from the Women with Vasomotor Symptoms Associated with Menopause (WARM) Study. Menopause. 2025;32(1):38-44.
3. https://www.canada.ca/en/public-health/services/chronic-diseases/cancer/breast-cancer.html
4. Canadian Cancer Society. Hormone therapy for breast cancer. Accessed July 2026. Available at: https://cancer.ca/en/cancer-information/cancer-types/breast/treatment/hormone-therapy
5. Yuksel N, Evaniuk D, Huang L, et al. Guideline No. 422a: Menopause: Vasomotor Symptoms, Prescription Therapeutic Agents, Complementary and Alternative Medicine, Nutrition, and Lifestyle. J Obstet Gynaecol Can. 2021;43(10):1188-1204.
6. Cardoso F, Parke S, Brennan DJ, et al. Elinzanetant for vasomotor symptoms from endocrine therapy for breast cancer. N Engl J Med. Published online June 2, 2025.
7. Pinkerton JV, Simon JA, Joffe H, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS 1 and 2 randomized clinical trials. JAMA. 2024;332(16):1343-1354. doi:10.1001/jama.2024.14618.
8. Panay N, Joffe H, Maki PM, et al. Efficacy and long-term safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS-3. JAMA Intern Med. 2025;185(11):1319-1327.

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Bayer Inc.
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Find more information at www.bayer.ca

Source: Bayer Inc.