FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations

Regulatory approval: On July 2, 2025, the FDA granted accelerated approval to sunvozertinib (Zegfrovy) for adults with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations (FDA-approved test) after progression on/after platinum-based chemotherapy. Approval was supported by WU-KONG1B (NCT03974022), where sunvozertinib 200 mg daily achieved a confirmed ORR of 46% and median DOR of 11.1 months (BIRC). FDA also approved the Oncomine Dx Express Test as a companion diagnostic.

FDA accelerated approval: sunvozertinib for EGFR exon 20 insertion–mutant NSCLC (July 2, 2025)

Type: Regulatory approval (accelerated approval)

On July 2, 2025, the FDA granted accelerated approval to sunvozertinib (Zegfrovy; Dizal (Jiangsu) Pharmaceutical Co., Ltd.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

The FDA also approved Oncomine Dx Express Test (Life Technologies Corporation) as a companion diagnostic to aid detection of EGFR exon 20 insertion mutations in NSCLC patients who may be eligible for Zegfrovy.

Supporting efficacy evidence

Efficacy was evaluated in WU-KONG1B (NCT03974022), a multinational, open-label, dose-randomization trial. The primary efficacy population included 85 patients who received sunvozertinib 200 mg orally once daily with food until progression or intolerable toxicity.

  • Primary endpoint: Confirmed ORR per RECIST v1.1 by blinded independent review committee (BIRC)
  • ORR: 46% (95% CI, 35–57)
  • DOR: 11.1 months (95% CI, 8.2–not evaluable)

Key safety warnings (per label)

Warnings/precautions include ILD/pneumonitis, gastrointestinal, dermatologic, and ocular adverse reactions, and embryo-fetal toxicity.

Recommended dose: 200 mg once daily with food until disease progression or unacceptable toxicity.

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