Bayer said the U.S. FDA has accepted a supplemental New Drug Application for Lynkuet, also known as elinzanetant, and granted the filing priority review status. The application covers moderate to severe vasomotor symptoms in women receiving endocrine therapy for hormone receptor-positive breast cancer, an accelerated assessment timeline compared with a standard review. The Lynkuet filing is one part of the broader Bayer story, sitting within the Pharmaceuticals division of the €49.9b life science group and widening usage of a recently approved product alongside launches such as Nubeqa and Kerendia. Expanding Lynkuet into a breast cancer setting puts Bayer up against focused oncology groups including Pfizer and Novartis, making execution, safety outcomes and real-world uptake key to how much it offsets patent erosion elsewhere. The review is a single regulatory step that can read as either a strong proof point or a fresh execution risk for the Bayer narrative.
Novartis AG
Pfizer IncBayer AG NAFDA accepted Bayer's supplemental NDA for Lynkuet and granted priority review for vasomotor symptoms in breast cancer patients on endocrine therapy.
