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An oral drug for EGFR exon 20 insertion lung cancer that succeeded where mobocertinib failed; approved in China (2023) and the US (2025).
Sunvozertinib is a covalent EGFR tyrosine kinase inhibitor selective for exon 20 insertions and other uncommon EGFR mutations, with wild-type sparing and CNS penetration. Developed by Dizal, it is used in locally advanced or metastatic NSCLC with EGFR exon 20 insertions after platinum chemotherapy. The WU-KONG1B study reported response rates of about 45 to 50% after platinum, including intracranial responses, and supported approval in China in 2023 and FDA accelerated approval in July 2025. The WU-KONG28 phase 3 trial versus platinum-pemetrexed in the first line has reported positive progression-free survival. Diarrhoea, rash and raised creatine phosphokinase are the main side effects. Sunvozertinib succeeded where mobocertinib failed and gives exon 20 patients an oral option alongside amivantamab.
Covalent inhibitor selective for EGFR exon 20 insertions and other uncommon mutations with wild-type sparing and CNS penetration. Connects to EGFR.
1.Sunvozertinib slips into a pocket on EGFR.
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Sources: NICE search: sunvozertinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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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, as detected by an FDA-approved test
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 1.2 years later, when the FDA's table was read. source
| Region | Year | Indication |
|---|---|---|
| CN | 2023 | EGFR exon 20 insertion NSCLC after platinum |
| US | 2025 | Locally advanced/metastatic NSCLC with EGFR exon 20 insertions after platinum |
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Query for this drug: (TITLE:"Sunvozertinib" OR ABSTRACT:"Sunvozertinib" OR TITLE:"Zegfrovy" OR ABSTRACT:"Zegfrovy" OR TITLE:"DZD9008" OR ABSTRACT:"DZD9008") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Sunvozertinib, not a curated reading list.
Shares EGFR exon 20 insertion, EGFR exon 20 insertion, EGFR-mutated non-small-cell lung cancer, EGFR.
Shares EGFR exon 20 insertion, EGFR-mutated non-small-cell lung cancer, EGFR, Non-small-cell lung cancer.
Shares Dizal Pharmaceutical, EGFR-mutated non-small-cell lung cancer, Non-small-cell lung cancer.
Shares EGFR exon 20 insertion, EGFR mutation subtypes (exon 19 deletion, L858R, exon 20 insertion, T790M), Non-small cell lung cancer (KEGG map), EGFR.
Shares EGFR mutation subtypes (exon 19 deletion, L858R, exon 20 insertion, T790M), EGFR-mutated non-small-cell lung cancer, EGFR, Small-molecule kinase inhibitors.
Shares EGFR exon 20 insertion, EGFR exon 20 insertion, Non-small-cell lung cancer.
Shares EGFR mutation subtypes (exon 19 deletion, L858R, exon 20 insertion, T790M), Non-small cell lung cancer (KEGG map), EGFR, Non-small-cell lung cancer.
Shares EGFR mutation subtypes (exon 19 deletion, L858R, exon 20 insertion, T790M), EGFR-mutated non-small-cell lung cancer, EGFR, Small-molecule kinase inhibitors.