US FDA to consider Dizal’s first-in-class lung cancer drug

Shanghai-based Dizal Pharmaceutical (SSE: 688192) has made a submission to the US Food and Drug Administration, seeking approval for sunvozertinib.

The targeted treatment has been developed for advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. The drug is aimed at patients whose disease has progressed following platinum-based chemotherapy.

Sunvozertinib, an oral EGFR inhibitor, had previously been approved for use in China, where it was recognized as the only oral drug available for NSCLC patients with this specific mutation. The application submitted to the FDA follows promising results from the WU-KONG1 Part B study.