Zegfrovy FDA Approved for EGFR Exon 20 Non-Small Cell Lung Cancer

The FDA approved Zegfrovy for advanced NSCLC with EGFR exon 20 mutations after chemotherapy: stock.adobe.com.

The U.S. Food and Drug Administration (FDA) has 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, and whose disease has progressed on or after platinum-based chemotherapy.

The FDA also approved the Oncomine Dx Express Test to help identify EGFR exon 20 insertion mutations in patients with non–small cell lung cancer who may be eligible for treatment with Zegfrovy.

The major efficacy outcome measure was confirmed overall response rate (ORR), as evaluated by a blinded independent review committee (BIRC), according to RECIST v1.1. ORR represents the proportion of patients whose cancer shrinks or disappears following treatment. An additional efficacy outcome measure was duration of response (DOR) by BIRC, which indicates how long the cancer remains controlled after a response is achieved. The overall response rate was 46%, and the duration of response was 11.1 months.

Efficacy was evaluated in WU-KONG1B, a multinational, open-label, dose-randomization trial. Patients enrolled had locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations and had experienced disease progression on or after platinum-based chemotherapy. The primary analysis included 85 patients who received 200 milligrams of Zegfrovy orally once daily with food until disease progression or the development of intolerable side effects.

The Zegfrovy prescribing information includes several warnings and precautions. These include interstitial lung disease (a condition characterized by lung inflammation or scarring), gastrointestinal side effects, skin-related adverse events, ocular toxicity, and the potential risk of harm to a developing fetus.

The recommended Zegfrovy dose is 200 milligrams by mouth once daily with food, continued until disease progression or unacceptable toxicity.

This review utilized the Assessment Aid, a voluntary submission prepared by the sponsor to facilitate the FDA’s review process.

This application received priority review, and Zegfrovy was granted breakthrough therapy designation—both components of the FDA’s expedited programs for serious conditions. These programs are designed to accelerate the development and approval of therapies that address unmet medical needs.

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