FDA Grants Priority Review to Bayer's Lynkuet (elinzanetant) for Vasomotor Symptoms Tied to Breast Cancer Endocrine Therapy
核心洞察
The FDA accepted Bayer (搜索)'s supplemental New Drug Application and granted Priority Review for Lynkuet (搜索) (elinzanetant) in moderate to severe vasomotor symptoms (搜索) from breast cancer (搜索) endocrine therapy.
The filing rests on the Phase III OASIS-4 trial, in which 474 women with HR+ breast cancer (搜索) or its prevention were randomized 2:1 to elinzanetant or placebo.
Lynkuet (搜索) met its primary endpoints, reducing mean daily frequency of moderate to severe vasomotor symptoms (搜索) from baseline at weeks 4 and 12 versus placebo.
The U.S. Food and Drug Administration has accepted Bayer (搜索)'s supplemental New Drug Application (sNDA) for Lynkuet (搜索) (elinzanetant) and granted the application Priority Review, the company announced. The filing seeks approval for the treatment of moderate to severe vasomotor symptoms (搜索) (VMS, also known as hot flashes) in women receiving endocrine therapy for the treatment of breast cancer (搜索).
Lynkuet (搜索) is a dual neurokinin (NK) targeted therapy, acting as a neurokinin 1 (NK-1) and neurokinin 3 (NK-3) receptor antagonist. The 60 mg capsule formulation was approved by the FDA in October 2025 for the treatment of moderate to severe hot flashes due to menopause, making it the first and only dual NK-targeted therapy approved for that indication.
An Unmet Need in HR+ Breast Cancer Care
Bayer (搜索) frames the new indication as addressing a treatment gap. "Currently, there are no FDA approved treatment options for moderate to severe vasomotor symptoms (搜索) associated with endocrine therapy in patients with HR+ breast cancer (搜索) 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."
In the U.S., breast cancer (搜索) accounts for 30% of all cancers in women, with hormone receptor-positive (HR+) cancers comprising approximately 70% of all breast cancer cases. American Society of Clinical Oncology guidelines recommend endocrine therapy for HR+ breast cancer with a minimum duration of use of 5 years, with potential extension to 10 years based on cancer type and other clinical considerations. Hot flashes are a common side effect of endocrine therapy.
"Endocrine therapy is a standard of care for many women facing HR+ breast cancer (搜索) and can commonly cause side effects such as vasomotor symptoms (搜索)," said OASIS-4 Primary Investigator Fatima Cardoso, MD, FESMO, Director of the Breast Unit at Centre Antoine Lacassagne and the 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."
OASIS-4 Trial Design and Results
The sNDA is based on results from the Phase III OASIS-4 trial, a 52-week, double-blind, randomized, placebo-controlled interventional study conducted at 90 sites outside of the U.S. A total of 474 women aged 18 to 70 years with moderate to severe VMS associated with endocrine therapy for HR+ breast cancer (搜索) 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).
According to Bayer (搜索), Lynkuet (搜索) met the primary endpoints of reducing the mean daily frequency of moderate to severe VMS symptoms from baseline to week 4 and week 12 compared to placebo in women receiving endocrine therapy for treatment or prevention of HR+ breast cancer (搜索).
Common adverse events during the trial were headache, fatigue, and somnolence. During the placebo-controlled period of the study, covering the first 12 weeks, somnolence, fatigue, and diarrhea were reported more frequently with elinzanetant than with placebo.
The key findings were presented at ASCO 2025 and simultaneously published in the New England Journal of Medicine in June 2025.
Prior Approval in Menopausal Hot Flashes
The October 2025 FDA approval of Lynkuet (搜索) for moderate to severe hot flashes due to menopause was supported by data from three Phase III clinical trials, OASIS-1, OASIS-2 and OASIS-3. Efficacy in that indication was demonstrated in the first 12 weeks of two randomized, double-blind, placebo-controlled, multicenter 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.
Safety was evaluated across the three randomized, double-blind, placebo-controlled, multicenter trials in 1,420 women. In OASIS-3, 627 women received Lynkuet (搜索) or placebo for up to 52 weeks to evaluate long-term safety.
Safety Profile
Lynkuet (搜索) is contraindicated in pregnancy. The label warns of central nervous system effects and daytime impairment, including somnolence, fatigue, vertigo, dizziness and presyncope, and advises patients who experience these effects not to drive or perform hazardous activities until they resolve. The label also flags increased liver blood test values, with liver enzyme testing required before starting treatment and 3 months after, and a risk of pregnancy loss and seizure. Patients are advised to avoid grapefruit and grapefruit juice during treatment. Common side effects listed in the prescribing information include headache, fatigue, dizziness, drowsiness, abdominal pain, rash, diarrhea and muscle spasms.