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FDA Grants Priority Review to Sunvozertinib for EGFR Exon 20 Insertion-Mutated NSCLC

  • The FDA granted priority review to sunvozertinib for treating advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.
  • This decision was based on efficacy and safety data from the WU-KONG1 trial, which demonstrated promising results.
  • Abenacianine, a tumor-targeted fluorescent imaging agent, received fast track designation for visualizing lung tumors, based on phase 2 study results.
The U.S. Food and Drug Administration (FDA) has granted priority review to sunvozertinib for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations. This regulatory action follows encouraging efficacy and safety outcomes observed in the WU-KONG1 clinical trial.
The priority review designation expedites the FDA's review process, potentially bringing sunvozertinib to market sooner for patients with this specific type of NSCLC. EGFR exon 20 insertion mutations are less common than other EGFR mutations and often present a therapeutic challenge.
The decision was based on data from the WU-KONG1 trial, which evaluated the efficacy and safety of sunvozertinib in patients with advanced NSCLC whose tumors harbored EGFR exon 20 insertion mutations. The study demonstrated promising results, warranting the FDA's priority review.
In related news, abenacianine, a novel tumor-targeted fluorescent imaging agent, has received fast track designation from the FDA. This designation aims to accelerate the development and review of abenacianine for visualizing lung tumors. The fast track designation was supported by safety and efficacy data from a phase 2 clinical trial, highlighting its potential to improve the detection and management of lung cancer.
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Reference News

[1]
January 2025 FDA Brief
targetedonc.com · Jan 26, 2023

FDA prioritizes sunvozertinib review for EGFR+ NSCLC treatment, citing WU-KONG1 trial's efficacy and safety data.

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