Bayer's Lynkuet wins FDA priority review for breast cancer symptom use
The agency will speed its review of the menopause drug for hot flashes linked to breast cancer hormone therapy
Published
The US Food and Drug Administration has granted priority review to Bayer's Lynkuet, also known as elinzanetant, for use in breast cancer patients experiencing hot flashes caused by endocrine therapy. Priority review shortens the FDA's decision timeline compared with a standard review.
Lynkuet is a non-hormonal, oral drug that blocks NK-1 and NK-3 receptors. It was first approved for moderate to severe hot flashes tied to menopause and has since been cleared in the European Union for both menopause and breast-cancer-related hot flashes, according to pharmaphorum. Around 70% of breast cancer diagnoses are hormone-receptor-positive, and patients on endocrine therapy for that type of tumor commonly experience hot flashes as a side effect, pharmaphorum reported.
Bayer's application drew on the Phase III OASIS 4 study, run outside the United States in women with hormone-receptor-positive breast cancer on endocrine therapy, BioSpace reported. Data presented at a cancer conference and published in the New England Journal of Medicine showed more than 70% of patients on elinzanetant had at least a 50% reduction in moderate-to-severe hot flashes within three months, according to Benefits and Pensions Monitor. The FDA had earlier extended its review of the drug by up to 90 days after seeing the breast cancer trial results, without raising concerns about its overall approvability, the outlet reported.
The priority review tightens Bayer's path to market but does not guarantee approval or a competitive edge. Eli Lilly's Inluriyo has already won two approvals within a year on strong efficacy data, setting a high bar for any new entrant in the same category.