FDA Grants Priority Review for Bayer's Lynkuet to Treat Hot Flashes in Breast Cancer Patients

The U.S. FDA has granted Priority Review to Bayer's supplemental New Drug Application for Lynkuet (elinzanetant). This review targets the treatment of moderate to severe vasomotor symptoms, or hot flashes, in women receiving endocrine therapy for breast cancer, based on Phase III study results. The drug was previously approved for menopausal hot flashes, and this action could expand its therapeutic use to a specific patient population.