[FDA Accelerated Approval] New Oral TKI for Advanced NSCLC with EGFR Exon20 Insertions
On July 2, 2025, the FDA granted accelerated approval to Sunvozertinib (brand name: Zegfrovy) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations who have progressed on or after platinum-based chemotherapy.
Drug Summary
- Name: Sunvozertinib (Zegfrovy)
- Company: Dizal (Jiangsu) Pharmaceutical Co., Ltd.
- Indication: EGFR exon 20 insertion mutation–positive advanced or metastatic NSCLC (post-platinum)
- Mechanism: EGFR-targeted tyrosine kinase inhibitor (TKI)
- Dose: 200 mg orally, once daily with food
Clinical Trial: WU-KONG1B (NCT03974022)
A global, open-label Phase 1/2 study. Primary endpoint was confirmed objective response rate (ORR) per RECIST v1.1 by independent review.
- ORR: 46% (95% CI: 35–57)
- Duration of Response: Median 11.1 months (95% CI: 8.2, NE)
Safety Profile
Warnings and precautions in the label include:
- Interstitial lung disease (ILD)/pneumonitis
- GI, dermatologic, and ocular toxicities
- Embryo-fetal toxicity
Companion Diagnostic
On the same day, the FDA also approved the Oncomine Dx Express Test to detect EGFR exon 20 insertions for treatment eligibility.
Significance
This is the first accelerated approval of an oral TKI specifically for EGFR exon 20 insertion–positive NSCLC—a critical development for patients with limited targeted therapy options.
Comments