Sunvozertinib Now Available in US for EGFR Exon 20+ NSCLC

Sunvozertinib (Zegfrovy) is now available in the US for the treatment of adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) whose tumors harbor EGFR exon 20 insertion mutations, as detected by an FDA-approved test, and whose disease has progressed on or after platinum-based chemotherapy, according to a news release from the developer, AstraZeneca.¹

Sunvozertinib is the only approved oral, single-agent targeted therapy for these patients following platinum-based chemotherapy. The FDA granted sunvozertinib accelerated approval in July 2025 based on results from the phase 1/2 WU-KONG1B trial (NCT03974022).²

What supported the approval of sunvozertinib?

The FDA granted sunvozertinib accelerated approval based on findings from the open-label, dose-randomization WU-KONG1B trial, in which the agent demonstrated a confirmed overall response rate (ORR) of 46% (95% CI, 35%-57%) and a median duration of response (DOR) of 11.1 months among responders (n = 39; 95% CI, 8.2-not reached), as assessed by blinded independent central review. Among responding patients, 72% experienced a DOR of at least 6 months. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Sunvozertinib is administered at 200 mg orally once daily with food. The agent is now available in the US through the Zegfrovy Specialty Distribution and Pharmacy network.

Why is there an unmet need in EGFR exon 20 insertion NSCLC?

EGFR exon 20 insertion mutations represent a distinct and hard-to-treat subgroup of EGFR-mutated NSCLC that is associated with primary resistance to earlier-generation EGFR tyrosine kinase inhibitors and historically limited targeted treatment options. These mutations account for an estimated 10% of EGFR-mutated NSCLC cases, and real-world evidence has shown a 5-year overall survival rate as low as 8%.

“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,” said D. Ross Camidge, MD, PhD, director of thoracic oncology at the University of Colorado, in the news release.¹ “For these patients, sunvozertinib 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.”

What is the safety profile of sunvozertinib?

Sunvozertinib can cause severe and life-threatening interstitial lung disease (ILD)/pneumonitis, which occurred in 1.7% of patients in a safety population of 121 patients and led to discontinuation in 0.8%. The agent can also cause severe gastrointestinal adverse reactions; diarrhea occurred in 73% of patients (2.5% grade 3) and nausea and vomiting in 43% (3.3% grade 3). Safety data also reveal severe dermatologic reactions (68% of patients, including acneiform dermatitis), ocular toxicity (13%, including keratitis in 0.8%), and embryo-fetal toxicity.

The most common adverse reactions occurring in at least 20% of patients were diarrhea, rash, decreased appetite, stomatitis, fatigue, nausea, paronychia, vomiting, constipation, musculoskeletal pain, pruritus, dry skin, urinary tract infection, abdominal pain, and decreased weight. Administration with food is recommended to reduce gastrointestinal adverse reactions.

What is sunvozertinib, and what comes next?

Sunvozertinib is an oral, irreversible EGFR inhibitor that targets a wide spectrum of EGFR mutations with wild-type EGFR selectivity. It is included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for NSCLC as a category 2A recommended subsequent therapy option for patients with EGFR exon 20 insertion mutation–positive advanced or metastatic NSCLC. Additionally, a supplemental new drug application for approval in the first-line setting, based on results from the phase 3 WU-KONG28 trial (NCT05668988) presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, has been submitted to the FDA and China’s Center for Drug Evaluation, both of which have granted breakthrough therapy designation in that setting.

“As a leader in treating EGFR-mutated lung cancer, the US launch of [sunvozertinib] marks an important step forward in our commitment to this patient community,” said Mohit Manrao, senior vice president of US oncology at AstraZeneca, in the news release.¹ “By making [sunvozertinib] available in the US, we are bringing an oral, mutation-specific treatment option to a distinct patient population with substantial unmet need.”

References

1. Zegfrovy (sunvozertinib) now available in the US for patients with previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations. News release. AstraZeneca. October 22, 2026. Accessed October 22, 2026. https://tinyurl.com/2b3jc7jr
2. FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations. News release. FDA. July 2, 2025. Accessed October 22, 2026. https://tinyurl.com/4n4a75cb