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News
The FDA has granted priority review to elinzanetant (Lynkuet) for moderate-to-severe hot flashes in women with HR-positive breast cancer undergoing endocrine therapy. The decision is backed by the phase 3 OASIS-4 trial, where elinzanetant significantly cut vasomotor symptom frequency compared to placebo. The drug already holds FDA approval for menopausal hot flashes.
The FDA has granted priority review to a supplemental new drug application (sNDA) for elinzanetant (Lynkuet), a dual NK-1/NK-3 receptor antagonist, for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) in women with hormone receptor (HR)–positive breast cancer who are on endocrine therapy. This is a meaningful quality-of-life issue, as hot flashes are one of the most common and disruptive side effects of endocrine treatments like tamoxifen and aromatase inhibitors.
The sNDA is supported by the phase 3 OASIS-4 trial, a randomized, double-blind, placebo-controlled study of 474 women. Patients receiving elinzanetant 120 mg saw significant reductions in daily hot flash frequency as early as week 1, with benefits sustained through 52 weeks. The drug was generally well tolerated, with headache, somnolence, and fatigue among the most common side effects.
By the Numbers:
Why it matters: Endocrine therapy is a cornerstone of HR-positive breast cancer treatment, but hot flashes often lead patients to reduce or discontinue it — undermining cancer outcomes. A non-hormonal option like elinzanetant could help patients stay on life-saving therapy while managing a major side effect.
