Sunvozertinib

WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca today announced the successful completion of the previously announced exclusive license agreement with Dizal Pharmaceutical Co., Ltd for ZEGFROVY ® (sunvozertinib), an oral irreversible epidermal growth factor receptor ( EGFR ) inhibitor for patients with lung cancer. Through this agreement, AstraZeneca has acquired worldwide rights to develop and commercialize ZEGFROVY. ZEGFROVY is approved in the US and China for the 2nd-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. Patients with NSCLC with EGFR exon 20 insertion mutations experience a real-world five-year overall survival rate as low as 8% underscoring the unmet need for new treatment options. 1 ZEGFROVY is already available to patients in China in the 2nd-line setting and AstraZeneca will launch in the US during the fourth quarter of 2026 for this indication. Sunvozertinib (ZEGFROVY ) is included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) for NSCLC. It is recommended as a subsequent therapy option for patients with EGFR exon 20 insertion mutation-positive advanced or metastatic NSCLC. See NCCN Guidelines ® for detailed recommendations. 2 A supplemental New Drug Application for approval of ZEGFROVY in the 1st-line setting has been accepted by the US Food and Drug Administration (FDA), supported by positive results from the global WU-KONG28 Phase III trial of ZEGFROVY in 1st-line NSCLC with EGFR exon 20 insertion mutations. These data were presented as a Late-Breaking Abstract Oral Presentation at the 2026 American Society of Clinical Oncology Annual Meeting and simultaneously published in The New England Journal of Medicine . ZEGFROVY has also been submitted for approval in the 1st-line setting to China’s Center for Drug Evaluation (CDE). The US FDA and China’s CDE both granted Breakthrough Therapy Designation to ZEGFROVY in this setting. Financial considerations AstraZeneca will make an upfront payment of $600m to Dizal together with additional payments of up to $900m upon achievement of specific development, regulatory and sales-related milestones. Additionally, Dizal will receive tiered royalties on the global sales of ZEGFROVY. This transaction does not impact AstraZeneca’s financial guidance for 2026. IMPORTANT SAFETY INFORMATION Interstitial Lung Disease/Pneumonitis ZEGFROVY can cause severe and life-threatening interstitial lung disease (ILD)/pneumonitis. In the safety population of 121 patients, ILD/pneumonitis occurred in 1.7% of patients. ZEGFROVY was discontinued due to ILD/pneumonitis in 0.8% of patients. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, and fever). Immediately withhold ZEGFROVY in patients with suspected ILD/pneumonitis and permanently discontinue ZEGFROVY if ILD/pneumonitis is confirmed. Gastrointestinal Adverse Reactions ZEGFROVY can cause severe gastrointestinal adverse reactions including diarrhea, nausea, and vomiting. In the safety population of 121 patients, serious gastrointestinal adverse reactions occurred in 1.7% of patients, including 0.8% Grade 3 nausea. Diarrhea occurred in 73% of patients who received ZEGFROVY, including 2.5% Grade 3. Diarrhea leading to dosage interruption or dose reduction occurred in 5% of patients and required permanent discontinuation of ZEGFROVY in 0.8% of patients. Nausea and vomiting occurred in 43% of patients, including 3.3% Grade 3 events. Nausea and vomiting leading to dosage interruption or dose reduction occurred in 7% of patients and permanent discontinuation of ZEGFROVY in 0.8% of patients. Administer ZEGFROVY with food to reduce gastrointestinal adverse reactions. Monitor patients for gastrointestinal toxicity, and provide supportive care, including anti-diarrheals, anti-emetics, or fluid replacement, as indicated. Withhold, reduce the dose, or permanently discontinue ZEGFROVY based on severity. Dermatologic Adverse Reactions ZEGFROVY can cause severe rash including acneiform dermatitis and pruritus. Based on the safety population of 121 patients, dermatologic adverse reactions occurred in 68% of patients including 9% acneiform dermatitis. Grade 3 dermatologic adverse reactions were 7% rash, 0.8% acneiform dermatitis, and 0.8% pruritus. Instruct patients to use alcohol-free (eg, isopropanol-free, ethanol-free) emollient cream during treatment with ZEGFROVY and to avoid the use of irritating skin products (eg, products containing retinol or retinoic acid, benzoyl peroxides). Withhold, reduce the dose, or permanently discontinue ZEGFROVY based on severity. Ocular Toxicity ZEGFROVY can cause ocular toxicity including keratitis, dry eye symptoms, blurred vision, and visual impairment. Based on the safety population of 121 patients, ocular toxicity occurred in 13% of patients who received ZEGFROVY, including keratitis in 0.8% of patients. Promptly refer patients with new or worsening eye symptoms to an ophthalmologist. Advise discontinuation of contact lenses until ocular symptoms are evaluated. Withhold, reduce the dose, or permanently discontinue ZEGFROVY based on severity. Embryo-Fetal Toxicity ZEGFROVY can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, oral administration of sunvozertinib to pregnant animals during the period of organogenesis resulted in structural abnormalities at concentrations below the human exposure at the recommended dose based on area under the curve (AUC). Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with ZEGFROVY and for 2 weeks after the last dose, since ZEGFROVY can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ZEGFROVY and for 2 weeks after the last dose. Adverse Reactions The most common (≥20%) adverse reactions were: diarrhea, rash, decreased appetite, stomatitis, fatigue, nausea, paronychia, vomiting, constipation, musculoskeletal pain, pruritus, dry skin, urinary tract infection, abdominal pain and decreased weight. The most common (≥2%) Grade 3 or 4 laboratory abnormalities were: decreased lymphocytes, increased lipase, decreased hemoglobin, increased amylase, increased creatine kinase, decreased neutrophils, decreased potassium, increased aspartate aminotransferase, increased alanine aminotransferase, decreased sodium, increased magnesium, and increased alkaline phosphatase. Drug Interactions Strong CYP3A Inhibitors : Avoid concomitant use. If concomitant use cannot be avoided, reduce ZEGFROVY dose and monitor for increased ZEGFROVY adverse reactions. Strong and Moderate CYP3A Inducers : Avoid concomitant use. If concomitant use cannot be avoided, increase ZEGFROVY dose. Hormonal Contraceptives : Avoid concomitant use. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with ZEGFROVY and for 2 weeks after the last dose. Concomitant use of ZEGFROVY with CYP3A substrates decreased their plasma concentrations where minimal concentration changes may lead to therapeutic failure of hormonal contraceptives. Use in Special Populations Lactation : Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with ZEGFROVY and for 2 weeks after the last dose. Infertility : ZEGFROVY may impair fertility in females and males. The reversibility of the effects on females was not assessed. The effects on male fertility were reversible. INDICATION ZEGFROVY is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Please see complete Prescribing Information , including Patient Information for ZEGFROVY. Notes NSCLC Lung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths. 3 Lung cancer is broadly split into small cell lung cancer or NSCLC, the latter accounting for 80-85% of cases. 3-4 Approximately 75% of people are diagnosed with advanced NSCLC. 5 Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFR m NSCLC. 6-8 ZEGFROVY ® (sunvozertinib) ZEGFROVY ® (sunvozertinib) is an irreversible EGFR inhibitor targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. ZEGFROVY is approved in the US and China for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. Supplemental New Drug Applications for approval of ZEGFROVY in the 1st-line setting have also been submitted to the US Food and Drug Administration (FDA) and China’s Center for Drug Evaluation (CDE). The US FDA and China’s CDE both granted Breakthrough Therapy Designation to ZEGFROVY in this setting. AstraZeneca in lung cancer AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating in innovative approaches, the Company aims to match medicines to the patients who can benefit most. The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including osimertinib and gefitinib; durvalumab and tremelimumab-actl; sunvozertinib; fam-trastuzumab deruxtecan-nxki and datopotamab deruxtecan-dlnk in collaboration with Daiichi Sankyo; savolitinib in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action. AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca . References Bazhenova L, et al. Comparative clinical outcomes for patients with advanced NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations. Lung Cancer, 2021; 162, 154-161. National Comprehensive Cancer Network. Non-Small Cell Lung Cancer. (Version 6.2026). . Accessed July 2026. 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. World Health Organization. International Agency for Research on Cancer. Lung Cancer Fact Sheet. Available at: . Accessed August 2025. American Cancer Society. What Is Lung Cancer?. Available at: . Accessed August 2025. Chen HJ, et al. Long-term survival of advanced lung adenocarcinoma by maintenance chemotherapy followed by EGFR-TKI. Medicine. 2021;100(6):e24688. Keedy VL, et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor ( EGFR ) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27. Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and Histological Samples in Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol. 2013;6:2800-2812. Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples. J Clin Pathol. 2013;66:79-89. US-115844 Last Updated 9/26 Contacts Media Inquiries Lauren-Jei McCarthy +1 347 918 7001 US Media Mailbox: usmediateam@astrazeneca.com