Lynkuet (elinzanetant) - (OASIS-4)

September 25, 2026: Bayer announced the FDA accepted and granted Priority Review to its supplemental NDA for Lynkuet (elinzanetant) for moderate to severe vasomotor symptoms in women receiving endocrine therapy for treatment or prevention of HR+ breast cancer.

The filing is supported by the Phase III OASIS-4 trial, a 52-week, randomized, double-blind, placebo-controlled study at 90 sites outside the U.S. In 474 women aged 18-70, participants were randomized 2:1 to elinzanetant for 52 weeks (n=316) or placebo for 12 weeks followed by elinzanetant for 40 weeks (n=158). Lynkuet met the primary endpoints, reducing mean daily frequency of moderate to severe vasomotor symptoms from baseline to weeks 4 and 12 versus placebo.

Common adverse events were headache, fatigue, and somnolence; during the 12-week placebo-controlled period, somnolence, fatigue, and diarrhea were reported more often with elinzanetant than placebo.

Bayer said the OASIS-4 results were presented at ASCO 2025 and published in NEJM in June 2025. Lynkuet was previously approved by the FDA in October 2025 for moderate to severe hot flashes due to menopause, based on Phase III OASIS-1, OASIS-2, and OASIS-3 data.