Sunvozertinib Earns FDA Accelerated Approval in EGFR Exon 20+ NSCLC

Findings from WU-KONG1B (NCT03974022) support the accelerated approval of sunvozertinib for patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR exon 20 insertion mutations.

The FDA has granted accelerated approval to sunvozertinib (Zegfrovy) as a treatment for adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations as detected with an FDA-approved test following progression on or after platinum-containing chemotherapy, according to a press release from the agency.¹

Additionally, the agency approved the Oncomine Dx Express Test as a companion diagnostic for the detection of EGFR exon 20 insertion mutations among those with NSCLC who may candidates to receive treatment with sunvozertinib.

The agency based its decision on data from the phase 1/2 WU-KONG1B trial (NCT03974022), in which investigators assessed sunvozertinib at 200 mg orally once daily among 85 patients with metastatic or locally advanced NSCLC harboring EGFR exon 20 insertion mutations.

Topline data showed that confirmed overall response rate (ORR) was 46% (95% CI, 35%-57%). Additionally, the study treatment produced a median duration of response (DOR) of 11.1 months (95% CI, 8.2-not reached).

Based on warnings and precautions from the prescribing information, toxicities reported in patients who received sunvozertinib included interstitial lung disease or pneumonitis, adverse gastrointestinal reactions, adverse dermatologic reactions, ocular toxicity, and embryo-fetal toxicity.

The trial's primary end points included safety and tolerability in part A as well as ORR per blinded independent review committee assessment using RECIST v1.1 criteria.² Secondary end points included DOR, disease control rate, and plasma concentration.

The FDA previously granted priority review to sunvozertinib as a treatment for this patient population in January 2025.³

References

1. 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 July 2, 2025. https://tinyurl.com/4n4a75cb
2. Assessing an oral EGFR Inhibitor, sunvozertinib in patients who have advanced non-small cell lung cancer with EGFR or HER2 mutation (WU-KONG1). ClinicalTrials.gov. Updated February 28, 2025. Accessed July 2, 2025. https://tinyurl.com/bddrzrp3
3. U.S. FDA granted priority review to Dizal's sunvozertinib new drug application. News release. Dizal Pharmaceutical. January 7, 2025. Accessed July 2, 2025. https://tinyurl.com/59syffnb