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Dizal's ZEGFROVY® (sunvozertinib) Receives FDA Accelerated Approval as the Only Targeted Oral Treatment for Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved ZEGFROVY® (sunvozertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), as detected by an FDA-approved test, whose disease has prog
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[{"type":"list","items":[{"val":[{"type":"text","content":"ZEGFROVY is the only approved targeted oral treatment for NSCLC with EGFR exon20ins","length":113,"tagName":"p"}]},{"val":[{"type":"text","content":"Approval follows the U.S. FDA's Priority Review and is supported by the pivotal WU-KONG1 Part B study, in which ZEGFROVY demonstrated statistically significant and clinically meaningful benefits to patients","length":215,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":328,"olType":false},{"type":"text","content":"SHANGHAI, July 2, 2025 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved ZEGFROVY® (sunvozertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.","length":586,"tagName":"p"},{"type":"image","alt":"Dizal logo (PRNewsfoto/Dizal Pharmaceutical)","displaySize":"","headline":null,"caption":"Dizal logo (PRNewsfoto/Dizal Pharmaceutical)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":153,"url":"https://media.zenfs.com/en/prnewswire.com/9e23c08c9c79c06f760f1f1494c86ccd"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/1u.Z_bHAhdSc0SaTeDpFdw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTI3MDtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/9e23c08c9c79c06f760f1f1494c86ccd","width":400,"height":153}},"href":"https://mma.prnewswire.com/media/2084187/Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"ZEGFROVY, which has received Priority Review and Breakthrough Therapy Designation from the FDA, is the only approved targeted oral treatment for NSCLC with EGFR exon20ins. This indication is approved under Accelerated Approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.","length":444,"tagName":"p"},{"type":"text","content":""We are proud to...
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