Business
Bayer : sevabertinib approved in Japan for patients with HER2-mutant non-small cell lung cancer
Bayer : sevabertinib approved in Japan for patients with HER2-mutant non-small cell lung
About this update from Bayer Ag
24 August 2026 | 08:29 AM Europe/Amsterdam Bayer's sevabertinib approved in Japan for patients with HER2-mutant non-small cell lung cancer Not intended for U.S. and UK Media Summary First targeted therapy approved in Japan for this indication, with use across all lines of therapy, including first-line treatment / Approval is based on results from the ongoing Phase I/II SOHO-01 trial evaluating the efficacy and safety of sevabertinib in patients with advanced HER2-mutant NSCLC / HER2-mutant NSCLC typically has a poor prognosis and limited treatment options Berlin, August 24, 2026 - The Ministry of Health, Labour, and Welfare (MHLW) in Japan has granted approval for Hyrnuo™ (sevabertinib) for the treatment of patients with HER2 (ERBB2) mutation-positive unresectable advanced or recurrent non-small cell lung cancer (NSCLC). In Japan, Hyrnuo is the first approved targeted therapy for this indication that can be used regardless of line of therapy, including as a first-line treatment. Sevabertinib is an oral, reversible, small molecule, tyrosine kinase inhibitor (TKI). " HER2- mutant NSCLC remains an area of significant unmet medical need. Sevabertinib has demonstrated clinically meaningful efficacy together with a manageable safety profile and offers a promising new treatment option for these patients. The availability of sevabertinib in the first-line setting, without restriction by HER2 mutation subtype, marks an important step forward in expanding treatment choices for both patients and healthcare professionals. We look forward to its potential as a new treatment option for patients," said Dr Koichi Goto, PhD, Chief of the Department of Thoracic Oncology at the National Cancer Center Hospital East in Japan. The MHLW approval is supported by data from the global Phase I/II SOHO-01 trial (NCT05099172). In patients with unresectable advanced or recurrent HER2-mutant NSCLC who had not received prior systemic therapy following diagnosis of advanced or recurrent disease, the primary endpoint of objective response rate (ORR) was 75.3% (95% CI: 63.9-84.7; N=73). Median duration of response (DOR) was 12.2 months (95% CI: 8.8-not estimable; N=73), and median progression-free survival (PFS) was 13.5 months (95% CI: 10.0-not estimable; N=73). The study also demonstrated a manageable safety profile, with the most frequently observed adverse events being diarrhea, rash, and paronychia. Adverse events leading to treatment discontinuation occurred in 3% of patients. 1 "The approval of sevabertinib by Japan's MHLW marks an important advancement for patients with advanced HER2-mutant NSCLC, a patient population that has historically faced limited treatment options," said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. "Supported by results from the ongoing SOHO-01 study, this latest approval advances our precision oncology strategy and builds on earlier approvals in both the U.S. and China. We continue to work with clinicians and diagnostic partners to support timely HER2 testing and appropriate access in line with the approved indication, with the goal of improving outcomes for people living with this difficult-to-treat form of lung cancer." In November 2025, sevabertinib, under the brand name Hyrnuo™, received U.S. Food and Drug Administration (FDA) accelerated approval for patients with previously treated advanced HER2 -mutant NSCLC. Earlier this year, sevabertinib was also approved by the National Medical Products Administration (NMPA) in China as monotherapy in adult patients with unresectable, locally advanced or metastatic NSCLC whose tumors have HER2 activating mutations, and who have received one prior systemic therapy. These approvals follow on from the U.S. FDA and the Center for Drug Evaluation (CDE) in China granting sevabertinib Breakthrough Therapy Designation for both first- and second-line use in patients with advanced HER2 -mutant NSCLC, highlighting its potential to provide substantial improvement over existing therapies. In May this year, the FDA granted sevabertinib Priority Review as a first-line treatment in this patient population recognizing its potential to address a critical unmet need. About Hyrnuo™ (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. 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 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 with 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 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com. Reference: 1. Herbert H. Loong, SOHO-01: Updated safety and efficacy of sevabertinib in patients with advanced HER2-mutant non-small cell lung cancer (NSCLC). ASCO Publications: https://ascopubs.org/doi/10.1200/JCO.2026.44.16_suppl.8622 Find more information at https://pharma.bayer.com Follow us on Facebook: http://www.facebook.com/bayer 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. Bayer AG is a holding company with operating subsidiaries worldwide. References to "Bayer" or "the company" herein may refer to one or more subsidiaries as context requires. Contacts Silvia Grosso Global Oncology Communications [email protected] +1 973 270 6828 Contact for investor inquiries: Bayer Investor Relations Team [email protected] +49 214 30-72704 Downloads 2026-0134e.pdf 2026-0134e.rtf Sign up for our Newsletter We will keep you informed about the latest news. Sign up Newsroom