FDA

Zegfrovy granted accelerated approval for NSCLC with EGFR exon 20 insertion mutations

July 8, 2025

Brand name: Zegfrovy

Generic name: sunvozertinib

Manufacturer: Dizal

Approval date: July 2, 2025

FDA granted accelerated approval to Zegfrovy (sunvozertinib) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

The agency also approved the Oncomine Dx Express Test (Life Technologies Corporation) as a companion diagnostic device to aid in detecting EGFR exon 20 insertion mutations in patients with NSCLC who may be eligible for treatment with Zegfrovy.

Efficacy

Approval was based on data from WU-KONG1B (NCT03974022), a multinational, open-label, dose randomization trial. Eligible patients had locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations with disease progression on or after platinum-based chemotherapy. The primary efficacy population comprised 85 patients who received sunvozertinib 200 mg PO once daily with food until disease progression or intolerable toxicity.

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. ORR was 46% (95% confidence interval [CI], 35, 57) and DOR was 11.1 months (95% CI, 8.2, not evaluable).

Safety

The prescribing information includes warnings and precautions for interstitial lung disease/pneumonitis, GI adverse reactions, dermatologic adverse reactions, ocular toxicity, and embryo-fetal toxicity.

Recommended dose

The recommended dosage of Zegfrovy is 200 mg PO once daily with food until disease progression or unacceptable toxicity.

Sources:

FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations. [News release]. 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20

Dizal’s Zegfrovy® (sunvozertinib) receives FDA accelerated approval as the only targeted oral treatment for non-small cell lung cancer with EGFR exon 20 insertion mutations. [News release]. 2025. https://www.prnewswire.com/news-releases/dizals-zegfrovy-sunvozertinib-receives-fda-accelerated-approval-as-the-only-targeted-oral-treatment-for-non-small-cell-lung-cancer-with-egfr-exon-20-insertion-mutations-302497351.html