Bayer Regulatory milestones build on FDA’s recent accelerated approval for previously treated HER2-mutant lung cancer patients
Bayer announced that regulatory authorities in both the United States and China have granted Breakthrough Therapy Designation to sevabertinib as a potential first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2-activating mutations. The designation was awarded by the U.S. Food and Drug Administration (FDA) and China’s Center for Drug Evaluation (CDE), underscoring the therapy’s potential to address a significant unmet medical need.Sevabertinib is an oral, reversible small-molecule tyrosine kinase inhibitor (TKI) designed to selectively target HER2-activating mutations. The latest regulatory recognition reflects growing confidence in the drug’s clinical profile, particularly for patients facing limited treatment options and historically poor outcomes.
The Breakthrough Therapy Designation granted by the U.S. FDA and the CDE in China for sevabertinib as a potential first-line therapy in advanced HER2-mutant NSCLC further underscores its potential to transform the lives of patients affected by this devastating disease,” said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division. “These milestones follow closely on the recent accelerated FDA approval in previously treated patients and reinforce Bayer’s commitment to advancing precision and personalized treatment options that address critical unmet needs and improve survival outcomes.”
The designations are supported by preliminary clinical data from cohort F of the ongoing Phase I/II SOHO-01 study (NCT05099172). This cohort includes patients who had not received prior systemic therapy, and results demonstrated encouraging efficacy and safety signals for sevabertinib in the first-line setting for HER2-mutant NSCLC.
Breakthrough Therapy Designation is intended to accelerate the development and regulatory review of medicines that show substantial improvement over existing therapies for serious or life-threatening conditions. The program enables closer collaboration between drug developers and regulatory agencies to expedite patient access to promising treatments.
In November 2025, sevabertinib, marketed under the brand name Hyrnuo™, received FDA accelerated approval for the treatment of patients with previously treated advanced HER2-mutant NSCLC. That approval was based on objective response rate (ORR) and duration of response (DOR) data from the SOHO-01 trial, specifically from cohort D (previously treated patients without prior HER2-targeted therapy) and cohort E (patients previously treated with HER2-directed antibody-drug conjugates).
With these latest regulatory advances, sevabertinib continues to emerge as a promising targeted therapy in the evolving treatment landscape for HER2-mutant lung cancer.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros.
