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Dizal’s Sunvozertinib Granted Breakthrough Therapy Designation

Designation approval for patients with NSCLC was based on results from the global multi-center phase I/II study (WU-KONG1).

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to Dizal’s sunvozertinib as the first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins) mutations.   This Breakthrough Therapy Designation approval was based on results from the global multi-center phase I/II study (WU-KONG1), which showed sunvozertinib as a single agent wi...

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