Zegfrovy is approved to treat NSCLC patients with EGFR exon 20 insertion mutations. Credit: Arif biswas/Shutterstock.

Dizal has received US Food and Drug Administration (FDA) approval for Zegfrovy (sunvozertinib) to treat adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), following progression on or after receiving platinum-based chemotherapy.

This approval makes Zegfrovy the only targeted oral treatment available in the US for NSCLC.

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Zegfrovy is designed to target a broad range of EGFR mutations while maintaining selectivity over wild-type EGFR.

The recommended dose is 200mg and the medicine is taken orally once daily.

The FDA approval was based on the multinational pivotal study WU-KONG1 Part B (WU-KONG1B) in which the safety and efficacy of the therapy were evaluated, focusing on patients with relapsed or refractory NSCLC.

Clinical data revealed that using Zegfrovy as a single agent resulted in a confirmed objective response rate (ORR) of 78.6% and median progression-free survival (mPFS) of 12.4 months among first-line treatment recipients.

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These findings highlight its potent antitumour activity and favourable safety profile, positioning it as an optimal initial therapy option for EGFR exon20ins NSCLC.

Dizal CEO Dr Xiaolin Zhang stated: “The accelerated approval of ZEGFROVY marks a significant milestone that underscores our commitment to developing groundbreaking new medicines for patients with high unmet medical needs around the world.”

The FDA simultaneously approvedThermo Fisher Scientific’s Oncomine Dx Express Test as a next-generation sequencing (NGS) companion diagnostic (CDx) tool for Zegfrovy.

This NSG test can identify patients with NSCLC who have EGFR Exon20 insertions when used with the Ion Torrent Genexus Dx system – delivering results within 24 hours to expedite treatment decisions.

Dizal recently completed patient enrolment for its Phase III WU-KONG28 study spanning 16 countries and regions.

In August 2023, Zegfrovy received clearance in China based on results from another significant trial, WU-KONG6.

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