Here Comes the Sun(vozertinib): Changes in Non-Small Cell Lung Cancer Treatment

Lung cancer—a tumor in the parenchyma or within the bronchi—is divided into 2 types: non-small cell lung cancer (NSCLC) and small cell lung cancer.¹ NSCLC accounts for around 85% to 90% of lung cancers. NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) represents an especially common type of NSCLC, with experts noting that these mutations are particularly difficult to treat due to their unique makeup and heightened heterogeneity.^2,6

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Guidelines published by the National Comprehensive Cancer Network (NCCN) are recognized as the standard of cancer care; they are updated at least annually. The most recent version of the NCCN Guidelines for NSCLC was updated at the beginning of July 2025.

Revisions in the 7^th version of the 2025 NCCN Guidelines for NSCLC include the medication sunvozertinib (Zegfrovy; Dizal Pharmaceuticals), which was recently granted accelerated approval by the FDA.³ Approval was based on the efficacy results—specifically, a robust overall response rate (ORR)—­from the WU-KONG1B study, a multinational, open-label, dose randomization trial.³

Sunvozertinib demonstrated an ORR of 46% when treating locally advanced or metastatic NSCLC with EGFR exon20ins.³ Critically, these robust efficacy rates were observed across patients with varying demographics and differing EGFR subtypes, with most patients achieving a sustained response.⁵ This evidence demonstrates that sunvozertinib can successfully treat NSCLC that has progressed during or after platinum-based chemotherapy.³ It is important to note continued approval of this medication is dependent on confirmatory trials.⁴

Based on the NCCN guidelines, patients should receive amivantamab-vmjw (Rybrevant; Johnson & Johnson) plus carboplatin-pemetrexed or systemic therapy as a first-line treatment (based on if an adenocarcinoma or squamous cell carcinoma is present). If the patient progresses from initial therapy, sunvozertinib is now recommended during subsequent lines of therapy. Table 1 details the treatment options for NSCLC (note sunvozertinib’s place in therapy).

The recommended dosing of sunvozertinib, a kinase inhibitor, for NSCLC is 200 mg by mouth once daily taken with food. Common adverse reactions possible with sunvozertinib include diarrhea, rash, and decreased appetite, among others. Furthermore, the prescribing information for sunvozertinib describes several warnings and precautions, including:⁴

• interstitial lung disease/pneumonitis,
• gastrointestinal,
• dermatologic,
• ocular toxicity, and
• embryo-fetal toxicity.

The recently published data from WU-KONG1 Part B demonstrated the strong efficacy of sunvozertinib in treating progression of NSCLC with EGFR exon 20 insertion mutations. This evidence enabled the FDA to grant the medication priority review, followed by an accelerated approval, making it the world’s first and only approved treatment for patients in this population. The NCCN, as of July 2025, updated their guidelines accordingly to reflect the evidence and approval.⁵ Oncology is an ever-changing field; it is important as pharmacists and technicians to stay up-to-date on current drug approvals and guideline updates. As the treatment paradigm of NSCLC continues to shift, pharmacists will be essential in communicating updates in standard-of-care treatment options and counseling patients on key management strategies.⁶

REFERENCES

1. Centers for Disease Control and Prevention. Lung Cancer Basics. Accessed July 15, 2025. https://www.cdc.gov/lung-cancer/about/index.html.

2. Novello S, Barlesi F, Califano R, et al. Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016;27(suppl 5):v1-v27. doi:10.1093/annonc/mdw326

3. Food and Drug Administration. FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20. Published July 2, 2025. Accessed July 16, 2025.

4. Zegfrovy (sunvozertinib). Package insert. Dizal (Jiangsu) Pharmaceutical Co., Ltd; 2025.

5. National Comprehensive Cancer Network. Non-Small Cell Lung Cancer (Version 7.2025). https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed July 15, 2025.

6. Halpern L. Sunvozertinib Approved by FDA as Oral Treatment of NSCLC With EGFR Exon 20 Insertion Mutations. Pharmacy Times. Published July 7, 2025. Accessed August 11, 2025. https://www.pharmacytimes.com/view/sunvozertinib-approved-by-fda-as-oral-treatment-of-nsclc-with-egfr-exon-20-insertion-mutations