{"entity":{"id":"sevabertinib","kind":"drug","name":"Sevabertinib","aka":[],"tldr":"Sevabertinib is an oral HER2 inhibitor for lung cancers with HER2 mutations, approved in November 2025 as an alternative to Enhertu and zongertinib.","summary":"Bayer's reversible HER2 TKI, derived from a Broad Institute alliance. SOHO-01: ORR ~64% in previously treated HER2-mutant NSCLC; accelerated approval 20 November 2025 for HER2 tyrosine-kinase-domain mutations after prior systemic therapy. First-line sNDA under priority review (2026). Diarrhoea and rash are the main toxicities; less ILD than T-DXd.","status":"approved","asOf":"2026-09-06","links":[{"label":"FDA approval (Bayer)","url":"https://www.bayer.com/en/us/news-stories/hyrnuo"},{"label":"OncLive report","url":"https://www.onclive.com/view/fda-grants-accelerated-approval-to-sevabertinib-in-her2-mutated-nonsquamous-nsclc"}],"tags":[],"related":[],"cancers":["nsclc","her2-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["her2"],"drugs":["zongertinib","trastuzumab-deruxtecan"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":["soho-01","nct06452277"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Hyrnuo","code":"BAY 2927088","modality":"Small-molecule kinase inhibitor (HER2)","mechanism":"Reversible, HER2-mutant-selective TKI sparing wild-type EGFR.","approvals":[{"region":"US","year":2025,"indication":"HER2 TKD-mutant non-squamous NSCLC after prior systemic therapy (accelerated)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2025-11-19","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 0.8 years later, when the FDA's table was read.","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-non-squamous-non-small-cell-lung-cancer","indication":"Treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy"},{"date":"2026-09-09","type":"accelerated-approval","region":"US","note":"FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous non-small cell lung cancer The confirmatory requirement was still open 0.0 years later, when the FDA's table was read.","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-locally-advanced-or-metastatic-non-squamous-non-small","indication":"Treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test"}]},"route":"/drugs/sevabertinib/","neighbours":{"cancer":[{"id":"her2-mutant-nsclc","kind":"cancer","name":"HER2-mutant non-small-cell lung cancer","route":"/cancers/her2-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":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"drug":[{"id":"trastuzumab-deruxtecan","kind":"drug","name":"Trastuzumab deruxtecan","route":"/drugs/trastuzumab-deruxtecan/"},{"id":"zongertinib","kind":"drug","name":"Zongertinib","route":"/drugs/zongertinib/"}],"company":[{"id":"bayer","kind":"company","name":"Bayer","route":"/companies/bayer/"}],"trial":[{"id":"nct06452277","kind":"trial","name":"A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-sma","route":"/trials/nct06452277/"},{"id":"soho-01","kind":"trial","name":"SOHO-01","route":"/trials/soho-01/"}]}}