Zegfrovy FDA Approval History
Last updated by Judith Stewart, BPharm on July 9, 2025.
FDA Approved: Yes (First approved July 2, 2025)
Brand name: Zegfrovy
Generic name: sunvozertinib
Dosage form: Tablets
Company: Dizal
Treatment for: Non Small Cell Lung Cancer
Zegfrovy (sunvozertinib) is an oral, irreversible, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for the treatment of locally advanced or metastatic non-small cell lung cancer patients with EGFR exon 20 insertion (exon20ins) mutations.
- Zegfrovy is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon20ins mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). - Roughly 2%-4% of NSCLC patients have EGFR exon20ins mutations, which are difficult to treat due to their unique spatial conformation, diverse mutation subtypes, and high heterogeneity.
- Zegfrovy contains sunvozertinib, an EGFR TKI that works by selectively targeting EGFR exon20ins and other mutations. The molecular structure of sunvozertinib enables it to overcome the inherent difficulties of targeting EGFR exon20ins mutations, which are difficult to treat with conventional EGFR inhibitors.
- FDA accelerated approval of Zegfrovy was supported by data from the multinational pivotal study WU-KONG1 Part B (WU-KONG1B). The major efficacy outcome measure was confirmed overall response rate (ORR) according to RECIST v1.1 as evaluated by a blinded independent review committee (BIRC). An additional efficacy outcome measure was duration of response (DOR) by BIRC. The ORR was 46% (95% CI: 35, 57) and DOR was 11.1 months (95% CI: 8.2, not evaluable).
- Zegfrovy is administered orally once daily with food until disease progression or unacceptable toxicity.
- Warnings and precautions associated with Zegfrovy include interstitial lung disease (ILD)/pneumonitis, gastrointestinal adverse reactions, dermatologic adverse reactions, ocular toxicity, and embryo-fetal toxicity.
- Common (≥20%) adverse reactions include diarrhea, rash, decreased appetite, stomatitis, fatigue, nausea, paronychia, vomiting, constipation, musculoskeletal pain, pruritus, dry skin, urinary tract infection, abdominal pain and decreased weight.
Common (≥2%) Grade 3 or 4 laboratory abnormalities include decreased lymphocytes, increased lipase, decreased hemoglobin, increased amylase, increased creatine kinase, decreased neutrophils, decreased potassium, increased aspartate aminotransferase, increased alanine aminotransferase, decreased sodium, increased magnesium, and increased alkaline phosphatase.
Development timeline for Zegfrovy
Further information
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