Author: pr-moritz
Last saved by: Roland Birkhoff
Company: Bayer
Document comments: V-2024-03-05

Not intended for U.S. and UK Media

Bayer receives Breakthrough Therapy Designation in the U.S. and China for sevabertinib as a first-line treatment for patients with HER2-mutant non-small cell lung cancer
•	The U.S. Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) in China have granted Breakthrough Therapy Designation to expedite the development of sevabertinib for first-line use in patients with HER2-mutant NSCLC given its potential to provide substantial benefit over available therapies in an area of high unmet need
•	These latest regulatory milestones follow the recent accelerated approval by the FDA for sevabertinib in patients with previously treated advanced HER2-mutant NSCLC 

Berlin, January 6, 2026 – Bayer announced today that the U.S. Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) in China have granted Breakthrough Therapy Designation for sevabertinib as a first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with human epidermal growth factor receptor 2 (HER2) activating mutations. Sevabertinib is an oral, reversible, small molecule, tyrosine kinase inhibitor (TKI) that targets HER2-activating mutations. 

“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
underscore its potential to transform the lives of patients affected by this devastating cancer, which has limited treatment options and poor prognosis," said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division. “These latest regulatory milestones closely follow the recent accelerated FDA approval for sevabertinib in previously treated advanced HER2-mutant NSCLC and highlight Bayer’s commitment to develop precise and personalized healthcare solutions that address critical unmet needs and help improve outcomes and extend survival for these patients.” 

The Breakthrough Therapy Designations are supported by preliminary clinical evidence from cohort F (patients who had not previously received treatment) of the ongoing Phase I/II SOHO-01 Study (NCT05099172) evaluating the efficacy and safety of sevabertinib in patients with locally advanced or metastatic NSCLC with HER2-activating mutations. 

Breakthrough Therapy Designation is a process designed to expedite the development of novel medicines that are intended for the prevention or treatment of serious, life-threatening diseases or conditions that severely impact the quality of life for which there is no existing treatment, or where sufficient evidence indicates advantages of the novel drug over available treatment options.

In November 2025, sevabertinib under the brand name Hyrnuo™ received FDA accelerated approval for patients with previously treated advanced HER2-mutant NSCLC based on objective response rate (ORR) and duration of response (DOR) data from the SOHO-01 trial (from cohort D - previously treated patients who had not received HER2-targeted therapy and cohort E - patients who had previously received HER2-directed antibody-drug conjugates). 

About sevabertinib
Sevabertinib is a new, oral, reversible, small molecule, tyrosine kinase inhibitor (TKI) that potently inhibits mutant human HER2, including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR), with high selectivity for mutant vs wild-type EGFR. Sevabertinib works by blocking certain enzymes called tyrosine kinases, which are involved in the growth of cancer cells. Reversible TKIs can temporarily block their targets, allowing for more precise control over treatment and potentially reducing long-term side effects compared to irreversible TKIs. 

Sevabertinib is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA.

As part of its clinical development program, alongside the SOHO-01 trial, sevabertinib is also being studied in patients in the Phase III SOHO-02 trial (NCT 06452277) evaluating sevabertinib in treatment naïve patients with HER2-mutant NSCLC and in the panSOHO study (NCT06760819) in patients with metastatic or unresectable solid tumors harboring HER2-activating mutations, excluding advanced NSCLC. 

About Non-Small Cell Lung Cancer (NSCLC)
Lung cancer is the leading cause of cancer-related deaths worldwide. NSCLC is the most common type of lung cancer, accounting for more than 85% of cases. Activating HER2 mutations are found in 2% to 4% of patients with advanced NSCLC. 80% of people diagnosed with NSCLC have already progressed to advanced stages, which makes it more difficult to treat. Patients with HER2-mutant NSCLC currently face limited treatment options, highlighting an urgent need for more effective therapies.

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. The oncology franchise at Bayer includes several marketed products across diverse indications and multiple compounds in different stages of clinical development. We have a wealth of expertise in areas including: Tumor Intrinsic Pathways, Targeted Radionuclide Therapies, and Next-Generation Immuno-Oncology. We are advancing prostate cancer treatment from early to metastatic stage, with the goal of extending survival while limiting side effects. Part of Bayer’s focus on innovative precision oncology treatments, includes an approved TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion, the oncogenic driver of tumor growth and spread.

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. For more information, go to www.bayer.com.

Contact for media inquiries:
Silvia Grosso, phone +1 973 270 6828
Email: silvia.grosso@bayer.com

Contact for investor inquiries:
Bayer Investor Relations Team, phone +49 214 30-72704 
Email: ir@bayer.com 
www.bayer.com/de/investoren/ir-team

Find more information at https://pharma.bayer.com/
Follow us on Facebook: http://www.facebook.com/bayer

sg	(2025-0001)

Forward-Looking Statements 
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.