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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.

Development timeline for Zegfrovy

DateArticle
Jul  2, 2025Approval FDA Grants Accelerated Approval to Zegfrovy (sunvozertinib) for Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Jan  7, 2025U.S. FDA Granted Priority Review to Dizal's Sunvozertinib New Drug Application
Nov  8, 2024Dizal Submits New Drug Application to the U.S. FDA for Sunvozertinib in Treating Relapsed or Refractory Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Apr  7, 2024FDA Grants Breakthrough Therapy Designation to Sunvozertinib for the First-Line Treatment of Patients with advanced Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

Further information

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