• Bayer’s supplemental New Drug Application (sNDA) is based on results from the Phase III OASIS-4 investigational study for the treatment of moderate to severe vasomotor symptoms in women receiving endocrine therapy for the treatment or prevention of breast cancer.1
• Lynkuet® (elinzanetant) 60mg capsules was approved by the U.S. Food and Drug Administration (FDA) in October 2025 for the treatment of moderate to severe hot flashes due to menopause.2

WHIPPANY, N.J.--(BUSINESS WIRE)-- Today Bayer announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review designation for Lynkuet® (elinzanetant) under investigation for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) in women receiving endocrine therapy for treatment of breast cancer. First approved by the FDA in October 2025 for the treatment of moderate to severe VMS due to menopause, Lynkuet is a dual neurokinin (NK) targeted therapy, neurokinin 1 (NK-1) and neurokinin 3 (NK-3) receptor antagonist.2

“Currently, there are no FDA approved treatment options for moderate to severe vasomotor symptoms associated with endocrine therapy in patients with HR+ breast cancer in the U.S. This treatment gap underscores an important unmet medical need for this population,” said Kristie Baisden, DO, Vice President, U.S. Medical Affairs, Women’s Health at Bayer. “As a global leader in women’s healthcare, this priority review is an important milestone for Bayer and underscores our commitment to women’s health and making treatment options available. We look forward to working closely with the Agency as they review the application.”

The sNDA for Lynkuet is based on results of the Phase III OASIS-4 trial. Key details and findings from the study include:

• The OASIS-4 study was a 52-week, double-blind, randomized placebo-controlled Phase III interventional study conducted at 90 sites outside of the U.S. A total of 474 women 18 to 70 years of age with moderate to severe VMS associated with endocrine therapy for HR+ breast cancer or its prevention were randomized 2:1 to elinzanetant (n=316) for 52 weeks or placebo for 12 weeks, followed by elinzanetant for 40 weeks (n=158).1
• Lynkuet met the primary endpoints of reducing the mean daily frequency of moderate to severe VMS symptoms from baseline to week 4 and 12 compared to placebo, in women receiving endocrine therapy for treatment or prevention of HR+ breast cancer.1
• Common adverse events during the trial were headache, fatigue, and somnolence. During the placebo controlled period of the study for the first 12 weeks, somnolence, fatigue, and diarrhea were reported more frequently with elinzanetant than with placebo.1
• The key findings were presented at ASCO 2025 and simultaneously published in the New England Journal of Medicine (NEJM) in June 2025.

In the U.S., breast cancer accounts for 30% of all cancers in women, with HR+ cancers comprising approximately 70% of all breast cancer cases.3 HR+ breast cancer treatment guidelines from the American Society of Clinical Oncology recommend endocrine therapy, with a minimum duration of use of 5 years, with potential extension to 10 years based on cancer type and other clinical considerations.4 Hot flashes can be a common side effect of endocrine therapy treatment.1

“Endocrine therapy is a standard of care for many women facing HR+ breast cancer and can commonly cause side effects such as vasomotor symptoms,” said OASIS-4 Primary Investigator Fatima Cardoso, MD, FESMO Director Breast Unit, Centre Antoine Lacassagne and Advanced Breast Cancer (ABC) Global Alliance, Nice, France. “It’s important that we continue to learn more about vasomotor symptoms due to endocrine therapy as part of supporting women throughout their breast cancer care journey.”

The October 2025 FDA approval was supported by data from three Phase III clinical trials (OASIS-1, OASIS-2 and OASIS-3) evaluating the safety and efficacy of Lynkuet for the treatment of moderate to severe hot flashes due to menopause.2,5,6

Product Indication and Important Safety Information

INDICATION

What is LYNKUET® (elinzanetant)?

LYNKUET is a prescription medicine used to reduce moderate to severe hot flashes (also known as vasomotor symptoms) due to menopause. LYNKUET is not a hormone. Hot flashes are feelings of warmth in the face, neck, and chest, or sudden intense feelings of heat and sweating.

IMPORTANT SAFETY INFORMATION

Do not take LYNKUET if you:

• are pregnant

Before you use LYNKUET, tell your healthcare provider about all of your medical conditions, including if you:

• have liver problems
• have a history of seizures or have a condition that may increase your risk of having a seizure
• are pregnant or planning to become pregnant. LYNKUET may harm your unborn baby. Women who can become pregnant should talk to their healthcare provider to exclude pregnancy before starting treatment with LYNKUET and use effective birth control during and for 2 weeks after stopping treatment.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LYNKUET may affect the way other medicines work, and other medicines may affect how LYNKUET works.

What should I avoid while taking LYNKUET?

• Avoid eating grapefruit or drinking grapefruit juice during treatment with LYNKUET.
• LYNKUET may cause you to feel drowsy, if you experience this avoid driving and other hazardous activities until these effects go away.

LYNKUET can cause serious side effects, including:

• Central nervous system (CNS) effects and daytime impairment. LYNKUET can cause difficulty staying awake (somnolence) and other nervous system effects including fatigue, having a spinning feeling (vertigo), dizziness, and feeling faint (presyncope). If you experience these effects, you should not drive or do hazardous activities until these effects go away.
• Increased liver blood test values. LYNKUET may cause increased liver enzymes. Your healthcare provider will do a blood test to check your liver before you start and 3 months after taking LYNKUET. Stop taking LYNKUET and tell your healthcare provider right away if you have the following signs or symptoms that suggest liver problems:
  • feeling more tired than you do usually
  • decreased appetite
  • nausea
  • vomiting
  • itching
  • yellowing of the eyes or skin (jaundice)
  • pale feces
  • dark urine
  • pain in the stomach (abdomen)
• Risk of pregnancy loss. Taking LYNKUET while pregnant may cause loss of pregnancy or stillbirth. If you think you are pregnant, stop taking LYNKUET and tell your healthcare provider right away.
• Risk of seizure. Seek medical attention right away if you have loss of consciousness or seizure.

Common side effects of LYNKUET include:

• headache
• fatigue
• dizziness
• feeling drowsy or sleepy
• stomach (abdominal) pain
• rash
• diarrhea
• muscle spasms

Tell your healthcare provider if you have any side effects that do not go away. These are not all the possible side effects of LYNKUET.

LYNKUET is available by prescription only.

You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088. For Bayer products, you can report these directly to Bayer by clicking here

For important information about LYNKUET, please see the Full Prescribing Information

About Lynkuet® (elinzanetant)

Lynkuet® (elinzanetant) 60mg capsules is an FDA-approved, hormone-free prescription treatment for moderate to severe hot flashes due to menopause. Lynkuet is the first and only dual neurokinin (NK) targeted therapy, neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist approved for the treatment of moderate to severe hot flashes due to menopause.

About the OASIS-1, 2 and 3 trials

The FDA approval of Lynkuet® (elinzanetant) 60mg capsules is supported by data from three Phase III clinical trials that evaluated the safety and efficacy of Lynkuet for the treatment of moderate to severe hot flashes due to menopause. The efficacy of Lynkuet for the treatment of moderate to severe hot flashes due to menopause was demonstrated in the first 12 weeks of two randomized, double-blind, placebo-controlled, multicenter clinical trials, OASIS-1 and OASIS-2, in 796 menopausal women. The co-primary efficacy endpoints in both trials were the mean change in frequency and severity of moderate to severe hot flashes from baseline to weeks 4 and 12, including day and night hot flashes. The safety of Lynkuet was evaluated in three randomized, double-blind, placebo-controlled, multicenter clinical trials (OASIS-1, OASIS-2 and OASIS-3) in 1,420 women. In OASIS-3, 627 women received Lynkuet or placebo for up to 52 weeks to evaluate long-term safety.

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.

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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 conform them to future events or developments.

References

1. Cordoso, F, Parke S, Brennan DJ, et. al. Elinzanetant for Vasomotor Symptoms from Endocrine Therapy for Breast Cancer. N Engl J Med 2025;393:753-763.
2. LYNKUET® (elinzanetant) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; August 2026.
3. Huang H, Wei T, Zhang A, et al. Trends in the incidence and survival of women with hormone receptor-positive breast cancer from 1990 to 2019: a large population-based analysis. Sci Rep. 2024;14(1):23690. Published 2024 Oct 10. doi:10.1038/s41598-024-74746-1
4. Burstein HJ, Temin S, Anderson H, et al. Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: American society of clinical oncology clinical practice guideline focused update. J Clin Oncol. 2014;32(21):2255-2269. doi:10.1200/JCO.2013.54.2258
5. 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
6. Panay N, Joffe H, Maki PM, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: a phase 3 randomized clinical trial. JAMA Intern Med. Published online September 8, 2025. doi:10.1001/jamainternmed.2025.0056

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Polina Miklush

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+1-862-431-8817

Source: Bayer