FDA grants accelerated approval for advanced non-small cell lung cancer treatment

Ella Day | July 4, 2025 | News story | Medical Communications, Research and Development |  Breakthrough Therapy Designation, Oncology, US Food and Drug Administration, Zegfrovy, clinical trial, non-small cell lung cancer, priority review 

The US Food and Drug Administration (FDA) has granted accelerated approval to Dizal Therapeutic’s Zegfrovy (sunvozertinib) for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR exon 20 insertion mutations. This covers patients whose disease has progressed following platinum-based chemotherapy.

Alongside the drug approval, the FDA approved the oncomine dx express test, developed by biotech company, Thermo Fisher Scientific, as a companion diagnostic to identify patients eligible for treatment with Zegfrovy. This provides a precision medicine approach to this difficult-to-treat population.

The approval of Zegfrovy was based on data from the WU-KONG1B trial. Among 85 eligible patients treated with sunvozertinib 200mg orally once daily with food, the confirmed overall response rate was 46%, as assessed by an independent review committee. The median duration of response was 11.1 months.

EGFR exon 20 insertion mutations are a rare subgroup of NSCLC, commonly associated with poor response to existing targeted therapies. The accelerated approval aims to address this significant unmet need.

Sunvozertinib’s prescribing information includes warnings for interstitial lung disease, gastrointestinal and dermatologic adverse reactions, ocular toxicity and embryo-fetal toxicity. The recommended dose is 200mg orally once daily until disease progression or unacceptable toxicity.

The application received breakthrough therapy designation and priority review, reflecting the FDA’s recognition of sunvozertinib’s potential to address this serious condition.

Ella Day
4/7/25