{"entity":{"id":"sunvozertinib","kind":"drug","name":"Sunvozertinib","aka":[],"tldr":"An oral drug for EGFR exon 20 insertion lung cancer that succeeded where mobocertinib failed; approved in China (2023) and the US (2025).","summary":"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.","status":"approved","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Sunvozertinib","links":[{"label":"FDA novel approvals 2025","url":"https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025"}],"tags":["gap-fill"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["egfr"],"drugs":[],"companies":["dizal"],"institutions":[],"pathways":[],"terms":["egfr-exon20-insertion"],"trials":["nct07182682","nct05668988","nct05712902","nct03974022","nct07079475","nct06295432","nct06276283"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Zegfrovy","code":"DZD9008","modality":"Small-molecule EGFR exon 20 insertion TKI (irreversible)","mechanism":"Covalent inhibitor selective for EGFR exon 20 insertions and other uncommon mutations with wild-type sparing and CNS penetration.","approvals":[{"region":"CN","year":2023,"indication":"EGFR exon 20 insertion NSCLC after platinum"},{"region":"US","year":2025,"indication":"Locally advanced/metastatic NSCLC with EGFR exon 20 insertions after platinum"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2025-07-02","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 1.2 years later, when the FDA's table was read.","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20","indication":"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"}]},"route":"/drugs/sunvozertinib/","neighbours":{"cancer":[{"id":"egfr-mutant-nsclc","kind":"cancer","name":"EGFR-mutated non-small-cell lung cancer","route":"/cancers/egfr-mutant-nsclc/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"}],"company":[{"id":"dizal","kind":"company","name":"Dizal Pharmaceutical","route":"/companies/dizal/"}],"term":[{"id":"egfr-exon20-insertion","kind":"term","name":"EGFR exon 20 insertion","route":"/terms/egfr-exon20-insertion/"},{"id":"egfr-mutation-subtypes","kind":"term","name":"EGFR mutation subtypes (exon 19 deletion, L858R, exon 20 insertion, T790M)","route":"/terms/egfr-mutation-subtypes/"}],"trial":[{"id":"nct07182682","kind":"trial","name":"A Phase 3 Study of Sunvozertinib Versus Placebo as Adjuvant Therapy in Patients With Early-Stage Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Ins","route":"/trials/nct07182682/"},{"id":"nct06295432","kind":"trial","name":"A Phase II Clinical Trial of DZD9008 in Combination With AZD4205 in Standard Treatment Failed NSCLC Patients With EGFR Mutations (WU-KONG21)","route":"/trials/nct06295432/"},{"id":"nct05668988","kind":"trial","name":"A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)","route":"/trials/nct05668988/"},{"id":"nct03974022","kind":"trial","name":"Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)","route":"/trials/nct03974022/"},{"id":"nct06276283","kind":"trial","name":"DZD9008 In Combination With Bevacizumab in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutation (WU-KONG29)","route":"/trials/nct06276283/"},{"id":"nct06864624","kind":"trial","name":"Perioperative Treatment of Sunvozertinib in Stage II-IIIB NSCLC","route":"/trials/nct06864624/"},{"id":"nct07079475","kind":"trial","name":"Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)","route":"/trials/nct07079475/"},{"id":"nct05712902","kind":"trial","name":"Sunvozertinib (DZD9008) in Pretreated Lung Cancer Patients with EGFR Exon20 Insertion Mutation (WU-KONG6)","route":"/trials/nct05712902/"}],"biomarker":[{"id":"egfr-exon-20-insertion","kind":"biomarker","name":"EGFR exon 20 insertion","route":"/biomarkers/egfr-exon-20-insertion/"}],"pathway":[{"id":"nsclc-signalling","kind":"pathway","name":"Non-small cell lung cancer (KEGG map)","route":"/pathways/nsclc-signalling/"}]}}