ZEGFROVY® (sunvozertinib) now available in the US for patients with previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations

First-line approval applications are also under review in the US and China, beyond the currently approved previously treated population.

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Only approved oral, single agent, targeted therapy for these patients following platinum-based chemotherapy

Launch expands AstraZeneca’s commitment to addressing substantial unmet need across the spectrum of EGFR-mutated lung cancer with a proven portfolio of medicines targeting EGFR mutations

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca today announced the US availability of ZEGFROVY^® (sunvozertinib) for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, and whose disease has progressed on or after platinum-based chemotherapy.¹

The US Food and Drug Administration granted accelerated approval to ZEGFROVY based on results from the WU-KONG1B trial.² In the open-label, dose randomization clinical trial, ZEGFROVY demonstrated a confirmed overall response rate of 46% (n=85; 95% confidence interval [CI] 35, 57) and a median duration of response of 11.1 months in those responders (n=39; 95% CI 8.2, NE).¹ Seventy-two percent of responding patients (n=39) observed duration of response for at least six months.¹ Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

EGFR exon 20 insertion mutations represent a distinct and hard-to-treat form of EGFR-mutated NSCLC.³ Patients have historically had limited targeted treatment options and poor outcomes, with real-world evidence showing a five-year overall survival rate as low as 8%.³

D. Ross Camidge, MD, PhD, Director, Thoracic Oncology, University of Colorado, said: “Patients with EGFR exon 20 insertion-mutated lung cancer have historically had limited targeted treatment options, particularly after their disease progresses following platinum-based chemotherapy.³ For these patients, sunvozertinib (ZEGFROVY^®) offers an oral, once-daily targeted treatment option that is recommended in clinical practice guidelines – giving patients and clinicians an option when treatment choices have historically been limited.¹”

Mohit Manrao, Senior Vice President, US Oncology, AstraZeneca, said: “As a leader in treating EGFR-mutated lung cancer, the US launch of ZEGFROVY marks an important step forward in our commitment to this patient community. People living with EGFR exon 20 insertion-mutated disease have historically had limited targeted treatment options following platinum-based chemotherapy.¹ By making ZEGFROVY available in the US, we are bringing an oral, mutation-specific treatment option to a distinct patient population with substantial unmet need.³”

ZEGFROVY can cause severe and life-threatening interstitial lung disease (ILD)/pneumonitis, severe gastrointestinal adverse reactions including diarrhea, nausea, and vomiting, severe rash including acneiform dermatitis and pruritus, ocular toxicity including keratitis, dry eye symptoms, blurred vision, and visual impairment, and fetal harm when administered to a pregnant woman.¹

Additionally, a Supplemental New Drug Application for approval in the 1st-line setting, based on Phase III WU-KONG28 trial results presented at last ASCO, has 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 have also both granted Breakthrough Therapy Designation in this setting.²

Sunvozertinib (ZEGFROVY^®) is included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for NSCLC as a Category 2A recommended subsequent therapy option for patients with EGFR exon 20 insertion mutation-positive advanced or metastatic NSCLC. See NCCN Guidelines^® for detailed recommendations.⁴

ZEGFROVY 200 mg is administered orally once daily with food. The medicine is now available in the US through the ZEGFROVY Specialty Distribution and Pharmacy network.¹ The medicine may also be acquired and distributed by Health System’s own-use Specialty Pharmacies.

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.¹

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

EGFR exon 20 insertion-mutated NSCLC

Lung cancer is broadly divided into NSCLC and small cell lung cancer, with NSCLC accounting for approximately 80% to 85% of cases. EGFR exon 20 insertion mutations are a distinct subgroup of EGFR alterations associated with primary resistance to earlier-generation EGFR tyrosine kinase inhibitors and historically limited targeted treatment options. EGFR exon 20 insertions account for an estimated 10% of EGFR-mutated NSCLC cases.¹

WU-KONG1B

WU-KONG1B is a multinational, open-label, dose randomization clinical trial that included patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based chemotherapy.¹ The efficacy population included 85 patients treated with ZEGFROVY 200 mg once daily. The major efficacy outcome measures were confirmed overall response rate and duration of response as assessed by blinded independent central review.

In WU-KONG1B, the confirmed overall response rate was 46% (n=85; 95% CI 35, 57), and the median duration of response was 11.1 months for those responders (n=39, 95% CI 8.2, NE). Among responding patients (n=39), 72% observed duration of response for at least six months.

ZEGFROVY^® (sunvozertinib)

ZEGFROVY is an oral, irreversible EGFR inhibitor targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In the US, ZEGFROVY is approved for the treatment of adults with locally advanced or metastatic NSCLC whose tumors have EGFR exon 20 insertion mutations, as detected by an FDA-approved test, and whose disease has progressed on or after platinum-based chemotherapy.¹

ZEGFROVY was granted 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 a confirmatory trial.

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 resistant and advanced settings. By defining new therapeutic targets and investigating 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 across targeted therapies, immuno-oncology medicines and antibody-drug conjugates, 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 catalyze 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.

About 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

1. ZEGFROVY^® (sunvozertinib) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2026.
2. Dizal. (2025, July 2). Dizal’s ZEGFROVY (sunvozertinib) receives FDA accelerated approval as the only targeted oral treatment for non-small cell lung cancer with EGFR exon 20 insertion mutations [press release]. PR Newswire.
3. 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. Assessed October 2026.
4. National Comprehensive Cancer Network. (2026). NCCN clinical practice guidelines in oncology (NCCN Guidelines): Non-small cell lung cancer (Version 6.2026). Assessed July 2026.

US-117675 Last Updated 10/26

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Source: AstraZeneca