Latest news with #HERNEXEOS
Business Wire
7 days ago
- Business
- Business Wire
Thermo Fisher Receives FDA Approval for NGS-Based Companion Diagnostic for New Non-Small Cell Lung Cancer Treatment
CARLSBAD, Calif.--(BUSINESS WIRE)--Thermo Fisher Scientific, the world leader in serving science, has received approval from the U.S. Food and Drug Administration (FDA) for its Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients who may be candidates for HERNEXEOS ® (zongertinib tablets), a tyrosine kinase inhibitor (TKI), developed by Boehringer Ingelheim. The test allows clinicians and pathologists to assess if non-small cell lung cancer (NSCLC) tumors harbor human epidermal growth factor receptor 2 (HER2/ERBB2) tyrosine kinase domain (TKD) activating mutations. Lung cancer is the second most common cancer in both men and women in the United States, with NSCLC accounting for about 85–90% of all lung cancer cases. 1 Among those diagnosed with NSCLC, approximately 2 to 4 percent of patients present with a HER2 mutation. 2 The FDA approved HERNEXEOS on August 8, 2025 as the first and only orally administered targeted therapy for adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. This indication was 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. More information and full Prescribing Information can be found at "This rare form of non-small cell lung cancer is linked to a poor prognosis and limited treatment options, making HERNEXEOS an important advancement in addressing the unmet needs of patients," said Vicky Brown, Senior Vice President and Head of Immunology, Oncology, and Eye Health, Boehringer Ingelheim. 'Through our collaboration with Thermo Fisher and leveraging the company's proven track record with companion diagnostics, we're pleased that patients have another tool that can be used to identify those with HER2 (ERBB2) tyrosine kinase activating mutations in non-small cell lung cancer.' The Oncomine Dx Target Test received its first approval by the FDA as an NGS CDx in 2017, followed by regulatory approvals in 20 countries for 11 biomarkers and over 20 targeted therapies (availability of these approvals vary per region). The test is reimbursed by government and commercial insurers in the U.S., Europe, Japan, South Korea, and Israel, covering more than 550 million lives globally. In the US alone, it is approved for targeted therapies in NSCLC, cholangiocarcinoma (CC), astrocytoma (AC) and oligodendroglioma (OG), anaplastic thyroid cancer (ATC), medullary thyroid cancer (MTC), and thyroid cancer (TC). "The FDA's approval of HERNEXEOS for previously treated patients living with HER2 (ERBB2)-mutant advanced non-small cell lung cancer signifies continued success in our efforts to develop timely and accessible companion diagnostics," said Kathy Davy, president of clinical next-generation sequencing at Thermo Fisher Scientific. 'We're continuing to expand our solutions for our pharma partners, as this approval quickly follows the recent FDA approval of our latest rapid NGS solution that can deliver results in as little as 24 hours.' For more information on the Oncomine Dx Target Test and Thermo Fisher's leadership in companion diagnostics, please visit About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit
Toronto Star
08-08-2025
- Health
- Toronto Star
U.S. FDA grants accelerated approval to Boehringer's HERNEXEOS® as first orally administered targeted therapy for previously treated patients with HER2-mutant advanced NSCLC
This press release is not intended for UK media. HERNEXEOS® (zongertinib tablets) approved based on an objective response rate of 75% (N=71), as demonstrated in the Beamion-LUNG 1 clinical trial1 Accelerated approval follows Priority Review and Breakthrough Therapy Designation granted by the U.S. FDA for the treatment of patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer
Yahoo
08-08-2025
- Health
- Yahoo
U.S. FDA grants accelerated approval to Boehringer's HERNEXEOS® as first orally administered targeted therapy for previously treated patients with HER2-mutant advanced NSCLC
Illustrative image This press release is not intended for UK media. HERNEXEOS® (zongertinib tablets) approved based on an objective response rate of 75% (N=71), as demonstrated in the Beamion-LUNG 1 clinical trial1 Accelerated approval follows Priority Review and Breakthrough Therapy Designation granted by the U.S. FDA for the treatment of patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer Ridgefield, Conn. U.S. and Ingelheim, Germany - Boehringer Ingelheim's HERNEXEOS® (zongertinib tablets) has been approved by the U.S. Food and Drug Administration (FDA). The kinase inhibitor is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.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 'With the approval of zongertinib, we have an effective, targeted, orally administered treatment option for patients with HER2 (ERBB2)-mutant non-small cell lung cancer in the U.S. that not only elicits a durable response but, importantly, has a manageable safety profile,' said Dr. John Heymach, MD, PhD, chair of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center, and coordinating investigator for the Beamion-LUNG 1 trial. 'In a patient population where there are currently limited treatment options, this approval represents a significant advancement in cancer care.' Accelerated approval is based on data from the Phase Ib Beamion-LUNG 1 trial, demonstrating an objective response rate of 75% (N=71), 6% of patients had a complete response and 69% of patients had a partial response and a duration of response of ≥6 months in 58% of patients (n=53).1 Positive results from the Beamion-LUNG 1 trial were previously presented at the American Association for Cancer Research (AACR) Annual Meeting 2025 and simultaneously published in The New England Journal of Medicine.2 Zongertinib demonstrated a manageable safety profile with a 2.9% discontinuation rate. In the pooled safety population, the most common (> 20%) adverse reactions were diarrhea (53%), hepatotoxicity (27%), rash (27%), fatigue (22%), and nausea (21%).1 'We are grateful to be able to bring forward HERNEXEOS, which has the potential to reset the benchmark for those living with HER2-mutant advanced non-small cell lung cancer, a condition associated with a particularly poor prognosis,' said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. 'Believing in the power of scientific innovation, we aim to provide meaningful improvements to this patient population. Recognizing its potential, we accelerated development to deliver this new treatment option to patients within four years of starting the first clinical trial." Harnessing the power of precision medicine by targeting HER2 mutations in lung cancer HER2 (ERBB2) mutations occur in approximately 2–4% of NSCLC cases and are associated with a poor prognosis and higher incidence of brain metastases.3,4,5 Alterations in the HER2 (ERBB2) gene, including mutations, amplification and overexpression, trigger uncontrolled cell proliferation, inhibiting cell death, and promoting tumor growth and spread.3,5 Comprehensive biomarker testing using next generation sequencing determines a patient's eligibility for treatment with zongertinib by identifying HER2 (ERBB2)-mutant advanced NSCLC.1,5 'The advocacy community is thrilled about the approval of zongertinib, as it is another testament to the importance of personalized options for lung cancer that allow for a much more targeted approach for a subgroup of patients who have been waiting many years for innovative treatments,' said Marcia Horn, President and CEO, International Cancer Advocacy Network and Executive Director of the Exon 20 Group/HER2 Warriors. 'Understanding your cancer's unique biomarkers, including HER2, through comprehensive testing is critical for all patients with NSCLC, as it can unlock targeted treatment options.' About non-small cell lung cancer (NSCLC) Lung cancer claims more lives than any other cancer type and the incidence is set to increase to over 3 million cases worldwide by 2040.5,6 NSCLC is the most common type of lung cancer.3 Due to a lack of symptoms and misdiagnoses,7 most patients with NSCLC present at stage III or IV, where the disease has metastasized locally or to other organs.8 The estimated 5-year survival rate historically has been less than 10% for metastatic disease.9,10,11 People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives.12,13,14 About zongertinib Zongertinib is a tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 (ERBB2).1 This orally administered, targeted therapy was approved as HERNEXEOS® (zongertinib tablets) under the FDA's Accelerated Approval Program, after securing Priority Review as well as Breakthrough Therapy and Fast Track Designations.1 The treatment is being evaluated in ongoing trials, across a range of advanced solid tumors with HER2 alterations. 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 and, 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 and The following information is intended for U.S. audiences only: About HERNEXEOS® HERNEXEOS® (zongertinib tablets) is a kinase inhibitor indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. Boehringer Ingelheim's CareConnect4Me patient support program Boehringer's goal is to make HERNEXEOS® (zongertinib tablets) easily accessible in the U.S. through a comprehensive patient support program, CareConnect4MeTM, that provides a broad range of access and clinical support solutions, including financial support services. For those in the U.S., visit or call 1-855-297-5903 to learn more. 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), an has a certain mutation in the human epidermal growth factor receptor 2 (HER2) gene, and who have previously received treatment by mouth or injection (systemic therapy). 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 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 diarrhea. liver problems Rash feeling tired nausea 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 or call 1-800-FDA-1088. For U.S. Healthcare Professionals, please see full Prescribing Information. CL--100065 07.28.2025 References: 1HERNEXEOS Prescribing Information 2Heymach, J. et al. Zongertinib in previously treated HER2-mutant non-small cell lung cancer. N Engl J Med. 2025;01-13. 3Baraibar I, et al. Novel drugs targeting EGFR and HER2 exon 20 mutations in metastatic NSCLC. Crit Rev Oncol Hematol. 2020;148:102906. 4Li, B.T. et al. Trastuzumab Deruxtecan in HER2-Mutant Non–Small-Cell Lung Cancer. N Engl J Med. 2022;386:241–51 5Zeng 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. 6International Agency for Research on Cancer – World Health Organization. Rates of trachea, bronchus and lung cancer. Available at: (Accessed: January 2025). 7American Cancer Society. Lung Cancer Early Detection, Diagnosis, and Staging. Available at: (Accessed: January 2025). 8Casal-Mouriño, A. et al. Epidemiology of stage III lung cancer: frequency, diagnostic characteristics, and survival. Transl Lung Cancer Res. 2021;10(1):506-518. 9National Cancer Institute Surveillance, Epidemiology, and End Results (SEER). 5-Year Survival (Accessed July 2025). 10Belaroussi, Y. et al. Survival outcomes of patients with metastatic non-small cell lung cancer receiving chemotherapy or immunotherapy as first-line in a real-life setting. Sci Rep. 2023.13, 9584. 11Simeone, J. C. et al. Treatment patterns and overall survival in metastatic non-small-cell lung cancer in a real-world US setting. Fut. Oncol. Lond. Engl. 2019. 15(30), 3491–3502. 12Valentine, T. R. et al. Illness Perceptions and Psychological and Physical Symptoms in Newly Diagnosed Lung Cancer. Health Psychol. 2022 Jun; 41(6): 379–388. 13Andersen, 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. 14Presley, 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. Attachment Illustrative imageError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
