Ridgefield, Conn. — Boehringer Ingelheim announced that HERNEXEOS® (zongertinib tablets) has been recommended as an initial treatment option for adult patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC) in the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer (Version 5.2026), updated on March 13, 2026.2 NCCN already recommends HERNEXEOS as a treatment option for patients with HER2 (ERBB2)-mutant advanced NSCLC who received prior systemic therapy. Its inclusion as a first-line treatment broadens the recommendation to encompass both treatment-naïve and previously treated patients, underscoring the promise of HERNEXEOS to address critical needs in both groups.
“The NCCN guidelines recommending HERNEXEOS as the first targeted therapy for adult patients who have not had prior treatment represents a significant advancement in cancer care, as more than half of patients with HER2-mutant non-small cell lung cancer do not respond to current treatment standards,” said Vicky Brown, U.S. Senior Vice President and Head of Oncology and Emerging Areas, Boehringer Ingelheim. “With an oral, once-daily medicine now available, oncologists can offer patients a targeted option early on and provide a new possibility that was not previously available.”
HERNEXEOS was approved by the U.S. Food and Drug Administration (FDA) on February 26, 2026 for the treatment of adult patients with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.1 This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1
The FDA also awarded a Commissioner’s National Priority Voucher for HERNEXEOS, underscoring its potential to meet critical patient needs for this rare and aggressive cancer.
CareConnect4MeTM, a comprehensive patient support program, provides a broad range of access and clinical support solutions, including financial support services, to patients who have been prescribed HERNEXEOS. To learn more, visit www.HERNEXEOS.com or call 1-855-297-5903.
About the National Comprehensive Cancer Network® (NCCN®)
The National Comprehensive Cancer Network® (NCCN®) is marking 30 years as a not-for-profit alliance of leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to defining and advancing quality, effective, equitable, and accessible cancer care and prevention so all people can live better lives. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) provide transparent, evidence-based, expert consensus-driven recommendations for cancer treatment, prevention, and supportive services; they are the recognized standard for clinical direction and policy in cancer management and the most thorough and frequently-updated clinical practice guidelines available in any area of medicine. The NCCN Guidelines for Patients® provide expert cancer treatment information to inform and empower patients and caregivers, through support from the NCCN Foundation®. NCCN also advances continuing education, global initiatives, policy, and research collaboration and publication in oncology. Visit NCCN.org for more information.
About HERNEXEOS® (zongertinib tablets)
HERNEXEOS (zongertinib tablets) is an irreversible tyrosine kinase inhibitor (TKI) that inhibits HER2 (ERBB2).1,3 HERNEXEOS has been approved by the U.S. Food and Drug Administration (FDA) as the first orally administered, targeted therapy for adult patients with HER2 (ERRB2)-mutant advanced non-small cell lung cancer.
Comprehensive biomarker testing with next-generation sequencing can detect HER2 (ERBB2) mutations in patients with advanced NSCLC, helping identify those who may be appropriate for HERNEXEOS.1,4
The treatment is being evaluated in ongoing trials, across a range of earlier stages and advanced solid tumors with HER2 alterations. Beamion LUNG-2 is an ongoing Phase III randomized controlled study evaluating zongertinib as a first-line treatment for patients with advanced NSCLC that has HER2 tyrosine kinase domain mutations (NCT06151574). Beamion LUNG-3 is a Phase III clinical trial investigating zongertinib as an adjuvant monotherapy in patients with early-stage, resectable NSCLC (Stage II-IIIB) with HER2 (ERBB2)-mutations (NCT07195695).
About HER2 (ERBB2)-mutant non-small cell lung cancer (NSCLC)
Lung cancer claims more lives than any other cancer type4 and the incidence is set to increase to over 3 million cases worldwide by 2040.5 NSCLC is the most common type of lung cancer.4 The condition is often diagnosed at a late stage,6 and fewer than 1 in 10 patients are alive five years after diagnosis.7 People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives.8,9,10 There remains a high unmet need for additional treatment options for people living with advanced NSCLC.
Up to 4% of lung cancers are driven by HER2 (ERBB2) mutations (or gene alterations).4 Mutations in HER2 (ERBB2) can lead to overexpression and overactivation, which can in turn result in uncontrolled cell production, inhibition of cell death and promotion of tumor growth and spread.11
About Boehringer Ingelheim in Oncology
We have a clear aspiration – to transform the lives of people with cancer by delivering meaningful advances, with the ultimate goal of curing a range of cancers. Boehringer Ingelheim’s generational commitment to driving scientific innovation is reflected by the company’s robust pipeline of cancer cell-directed and immuno-oncology investigational therapies, as well as the smart combination of these approaches. Boehringer’s ambition in oncology is to take a diligent and broad approach, creating a collaborative research network to tap into a diversity of minds, which is vital in addressing some of the most challenging, but potentially most impactful, areas of cancer research. Simply put, for Boehringer Ingelheim, cancer care is personal, today and for generations. Read more at Boehringer-Ingelheim.com/US.
About Boehringer Ingelheim
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at Boehringer-Ingelheim.com/
What is HERNEXEOS (zongertinib tablets)?
HERNEXEOS is a prescription medicine used to treat adults with a type of lung cancer called non–squamous non–small cell lung cancer (NSCLC) that:
- cannot be removed by surgery or that has spread to other parts of your body (metastatic), and
- has a certain mutation in the human epidermal growth factor receptor 2 (HER2) gene
Your healthcare provider will perform a test to make sure HERNEXEOS is right for you.
It is not known if HERNEXEOS is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Before taking HERNEXEOS, tell your healthcare provider about all of your medical conditions, including if you:
- have liver problems
- have heart problems
- have lung or breathing problems other than lung cancer
- are pregnant or plan to become pregnant. HERNEXEOS can harm your unborn baby
Females who are able to become pregnant:- Your healthcare provider will do a pregnancy test before you start treatment with HERNEXEOS
- Use an effective form of birth control (contraception) during treatment with HERNEXEOS and for 2 weeks after your last dose
- Talk to your healthcare provider about birth control methods that might be right for you during this time
- Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with HERNEXEOS
- are breastfeeding or plan to breastfeed. It is not known if HERNEXEOS passes into your breastmilk. Do not breastfeed during treatment and for 2 weeks after your last dose of HERNEXEOS
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. HERNEXEOS may affect the way other medicines work, and other medicines may affect how HERNEXEOS works.
Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.
What are the possible side effects of HERNEXEOS?
HERNEXEOS may cause serious side effects, including:
- liver problems. Liver problems are common with HERNEXEOS and can be severe and life-threatening. Your healthcare provider will do blood tests to check your liver function before you start taking HERNEXEOS and during your treatment. Tell your healthcare provider right away if you develop any signs and symptoms of liver problems, including:
- yellowing of your skin or the white part of your eyes (jaundice)
- dark or brown (tea colored) urine
- pain on the upper right side of your stomach area (abdomen)
- bleeding or bruising more easily than normal
- feeling very tired
- loss of appetite
- nausea or vomiting
- heart problems that may affect your heart’s ability to pump blood. HERNEXEOS can cause severe heart problems. Your healthcare provider will do tests to check your heart function before you start taking HERNEXEOS and during treatment. Tell your healthcare provider right away if you have any new or worsening symptoms of heart problems, including:
- feeling like your heart is pounding or racing
- dizziness
- tiredness
- feeling lightheaded
- shortness of breath
- loss of consciousness
- coughing
- swelling of your legs, ankles, or feet
- lung problems. HERNEXEOS can cause lung problems that are severe or life-threatening. Tell your healthcare provider right away if you have any new or worsening symptoms of lung problems, including trouble breathing, shortness of breath, cough, or fever
Your healthcare provider may temporarily stop, decrease your dose, or permanently stop treatment with HERNEXEOS if you have serious side effects.
The most common side effects of HERNEXEOS include:
- diarrhea. HERNEXEOS can cause severe diarrhea. Tell your healthcare provider right away if you have new or worsening diarrhea
- rash
- liver problems
- feeling tired
- nausea
- muscle and joint pain
- upper respiratory tract infection
The most common severe abnormal blood tests include decreased white blood cell count, increased liver function tests, and decreased potassium levels.
HERNEXEOS may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.
These are not all of the possible side effects of HERNEXEOS. Call your doctor for medical advice about side effects. For more information, ask your healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
CL-HER-100001 02.2026
For U.S. Healthcare Audiences, please see full Prescribing Information and Patient Information.
References
1 HERNEXEOS Prescribing Information
2 Referenced with permission from the NCCN Guidelines. © National Comprehensive Cancer Network 2025. All rights reserved. Accessed August 15, 2025. To view the most recent and complete version of the guidelines, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
3 Wilding B, Woelflingseder L, Baum A, et al. Zongertinib (BI 1810631), an Irreversible HER2 TKI, Spares EGFR Signaling and Improves Therapeutic Response in Preclinical Models and Patients with HER2-Driven Cancers. Cancer Discov. 2025;15(1):119-138. doi:10.1158/2159-8290.CD-24-
4 Zeng J, Ma W, Young RB, Li T. Targeting HER2 genomic alterations in non-small cell lung cancer. J Natl Cancer Cent. 2021 May 3;1(2):58-73.
5 International Agency for Research on Cancer – World Health Organization. Rates of trachea, bronchus and lung cancer. Available at: https://gco.iarc.fr/
6 Casal-Mouriño, A. et al. Epidemiology of stage III lung cancer: frequency, diagnostic characteristics, and survival. Transl Lung Cancer Res. 2021;10(1):506-518.
7 National Cancer Institute Surveillance, Epidemiology, and End Results (SEER). 5-Year Survival Rates. https://www.seer.
8 Valentine, T. R. et al. Illness Perceptions and Psychological and Physical Symptoms in Newly Diagnosed Lung Cancer. Health Psychol. 2022 Jun; 41(6): 379–388.
9 Andersen, B. L. et al. Newly diagnosed patients with advanced non-small cell lung cancer: A clinical description of those with moderate to severe depressive symptoms. Lung Cancer. 2020 Jul;145:195-204.
10 Presley, C. J. et al. Functional Disability Among Older Versus Younger Adults With Advanced Non–Small-Cell Lung Cancer. JCO Oncol Pract. 2021 May 3;17(6):e848–e858.
11 Galogre M, et al. A review of HER2 overexpression and somatic mutations in cancers, Critical Reviews in Oncology/Hematology, Volume 186, 2023, 103997