CAMBRIDGE, U.K. — October 22, 2026
AstraZeneca announced the U.S. availability of ZEGFROVY® (sunvozertinib) for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. The oral, once-daily targeted therapy received accelerated approval from the U.S. Food and Drug Administration (FDA) based on results from the WU-KONG1B clinical trial. AstraZeneca describes ZEGFROVY as the only approved oral, single-agent targeted therapy for this patient population following platinum-based chemotherapy. The launch expands the company’s portfolio of medicines targeting EGFR mutations and addresses an area of substantial unmet medical need. In WU-KONG1B, ZEGFROVY demonstrated a confirmed overall response rate of 46% among 85 patients, with a median duration of response of 11.1 months among the 39 responders. Seventy-two percent of responders maintained a response for at least six months. The treatment is included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as a Category 2A subsequent therapy option for eligible patients. The current indication is approved under accelerated approval based on response rate and duration of response, and continued approval may depend on verification of clinical benefit in confirmatory trials.
WU-KONG1B Results Support Accelerated Approval
The WU-KONG1B trial was a multinational, open-label, dose-randomization study evaluating sunvozertinib in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease progressed during or after platinum-based chemotherapy. The efficacy analysis included 85 patients treated with ZEGFROVY 200 mg once daily. The primary efficacy measures included confirmed overall response rate and duration of response, assessed by blinded independent central review. The confirmed overall response rate was 46% (95% confidence interval [CI], 35%–57%), while median duration of response among responders was 11.1 months (95% CI, 8.2 months to not estimable). Among the 39 responders, 72% experienced a response lasting at least six months. These results formed the basis for the FDA’s accelerated approval. EGFR exon 20 insertion mutations represent a distinct subgroup of EGFR alterations associated with limited treatment options and resistance to earlier-generation EGFR tyrosine kinase inhibitors. According to the company’s announcement, real-world evidence has reported five-year overall survival as low as 8% in this population. D. Ross Camidge, M.D., Ph.D., director of thoracic oncology at the University of Colorado, said patients whose disease progresses after platinum-based chemotherapy have historically had limited targeted treatment options. AstraZeneca’s U.S. Oncology leadership described the launch as an effort to provide a mutation-specific oral treatment for patients with significant unmet needs.
Sunvozertinib Targets EGFR Mutations With Specific Safety Risks
Sunvozertinib is an oral, irreversible EGFR inhibitor designed to target a broad range of EGFR mutations while maintaining selectivity over wild-type EGFR. ZEGFROVY is administered orally once daily with food at a recommended dose of 200 mg. The medicine is available in the United States through the ZEGFROVY Specialty Distribution and Pharmacy network, and health systems may also obtain and distribute it through their own-use specialty pharmacies. The prescribing information includes important warnings concerning potentially severe or life-threatening adverse reactions. ZEGFROVY can cause interstitial lung disease (ILD) or pneumonitis, severe gastrointestinal reactions, serious skin reactions, ocular toxicity and embryo-fetal harm. In the safety population of 121 patients, ILD or pneumonitis occurred in 1.7% of patients, while diarrhea occurred in 73%, nausea and vomiting in 43%, dermatologic adverse reactions in 68%, and ocular toxicity in 13%. Patients should be monitored for new or worsening respiratory symptoms, gastrointestinal toxicity, severe rash and eye symptoms. The prescribing information recommends withholding treatment when ILD or pneumonitis is suspected and permanently discontinuing treatment if it is confirmed. Other adverse reactions may require supportive care, dose interruption, dose reduction or discontinuation depending on severity. ZEGFROVY may also cause fetal harm, affect fertility and interact with certain medicines, including strong CYP3A inhibitors, CYP3A inducers and hormonal contraceptives. Patients should consult the full prescribing information and their healthcare professionals regarding precautions and medication management.
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AstraZeneca Advances First-Line Development Program
AstraZeneca is also pursuing the potential use of sunvozertinib earlier in the treatment pathway. The company has submitted a supplemental New Drug Application (sNDA) to the U.S. FDA and an application to China’s Center for Drug Evaluation (CDE) seeking approval in the first-line setting, based on results from the Phase 3 WU-KONG28 trial presented at the previous American Society of Clinical Oncology (ASCO) meeting. Both the U.S. FDA and China’s CDE have granted Breakthrough Therapy Designation for sunvozertinib in this setting. These designations support development and regulatory review but do not constitute approval for first-line use. AstraZeneca’s broader lung cancer strategy includes targeted therapies, immuno-oncology medicines and antibody-drug conjugates, with research spanning early-stage disease and advanced or treatment-resistant cancers. The company is also a founding member of the Lung Ambition Alliance, a global coalition focused on accelerating innovation in lung cancer. With ZEGFROVY now available in the United States for previously treated EGFR exon 20 insertion-mutated NSCLC, the company is expanding access to an oral targeted option while continuing to evaluate whether the therapy may benefit patients earlier in their treatment journey. The current indication remains limited to adults with locally advanced or metastatic disease that has progressed on or after platinum-based chemotherapy, as detected by an FDA-approved test.
Source: AstraZeneca, press release
