{"id":"disitamab-vedotin","rwe":[],"tags":[],"safety":{"safetySignals":[{"date":"","signal":"MYELOSUPPRESSION","source":"FDA FAERS","actionTaken":"Reported 17 times"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"Reported 13 times"},{"date":"","signal":"WHITE BLOOD CELL COUNT DECREASED","source":"FDA FAERS","actionTaken":"Reported 7 times"},{"date":"","signal":"ASTHENIA","source":"FDA FAERS","actionTaken":"Reported 6 times"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"Reported 6 times"},{"date":"","signal":"DISEASE PROGRESSION","source":"FDA FAERS","actionTaken":"Reported 5 times"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"Reported 5 times"},{"date":"","signal":"PRURITUS","source":"FDA FAERS","actionTaken":"Reported 5 times"},{"date":"","signal":"DECREASED APPETITE","source":"FDA FAERS","actionTaken":"Reported 4 times"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"Reported 4 times"}],"drugInteractions":[{"drug":"P-glycoprotein inhibitors","action":"Monitor","effect":"Increased risk of toxicity"},{"drug":"P-glycoprotein inducers","action":"Avoid","effect":"Decreased efficacy"},{"drug":"Strong CYP3A4 inhibitors","action":"Monitor","effect":"Increased risk of toxicity"},{"drug":"Strong CYP3A4 inducers","action":"Avoid","effect":"Decreased efficacy"},{"drug":"Live vaccines","action":"Avoid","effect":"Decreased efficacy of vaccine"},{"drug":"Other anticancer agents","action":"Monitor","effect":"Increased risk of toxicity"}],"commonSideEffects":[],"contraindications":["Patients with a known hypersensitivity to any component of the drug, particularly MMAE, should not receive this treatment. Additionally, caution is advised in patients with pre-existing liver or kidney impairments, as the drug's metabolism and excretion could be affected, leading to increased toxicity.Pregnant women and those who are breastfeeding should avoid using Disitamab Vedotin due to the potential risk of harm to the fetus or infant."],"specialPopulations":{"Pregnancy":"No specific information is available for this population.","Geriatric use":"No specific information is available for this population.","Paediatric use":"10 Pediatrics","Renal impairment":"Table 6: Summary of Safety by Baseline Renal Function","Hepatic impairment":"Table 5: Summary of Safety by Baseline hepatic Function"}},"trials":["NCT05831878","NCT07584733","NCT06157892","NCT07241793","NCT07504939","NCT04879329","NCT06966453","NCT05911295","NCT06003231","NCT07509424","NCT06145308","NCT07507526","NCT07498907","NCT07490990","NCT07474064","NCT07474324","NCT07446452","NCT07366840","NCT07315750","NCT07311577","NCT05837806","NCT07309770","NCT06210490","NCT05912816","NCT07207824","NCT06178159","NCT05980481","NCT07194005","NCT05851677","NCT06992362","NCT07172217","NCT07159217","NCT07151560","NCT07142200","NCT07117851","NCT07100184","NCT07093866","NCT07065435","NCT06540729","NCT06957561","NCT06944496","NCT06904573","NCT06558682","NCT06857747","NCT06642545","NCT05586061","NCT06791070","NCT05917158","NCT06730373","NCT06749860","NCT06561555","NCT06734182","NCT06663007","NCT06660511","NCT06650332","NCT06630871","NCT06572319","NCT06105008","NCT06560528","NCT06187506","NCT06378242","NCT06492317","NCT06487429","NCT06227156","NCT06389006","NCT06385873","NCT06383533","NCT05661357","NCT06233864","NCT06354231","NCT06221748","NCT06227117","NCT06155396","NCT06278870","NCT06227325","NCT06185400","NCT05302284","NCT05514158","NCT06155383","NCT05578287","NCT05940896","NCT06078982","NCT06074484","NCT06055153","NCT05979740","NCT05957757","NCT06015113","NCT06000033","NCT05982834","NCT05955209","NCT05928897","NCT05904964","NCT05912205","NCT05861635","NCT05847764","NCT05726175","NCT05723991","NCT05720533","NCT05649163","NCT05627414","NCT05493683","NCT05540483","NCT05495724","NCT05488353","NCT05333809","NCT05313906","NCT05113459","NCT05016973"],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=disitamab-vedotin","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-05-16T02:25:39.843303+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Disitamab-Vedotin","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:38:59.492982+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:38:57.958887+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:38:44.871140+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=disitamab-vedotin","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:38:58.904779+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Tubulin disrupting agent","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:38:59.492720+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL5095273/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:38:59.387210+00:00"}},"allNames":"disitamab vedotin","offLabel":[],"timeline":[],"aiSummary":"Disitamab vedotin is a marketed drug by Pfizer Inc. for the treatment of HER2-positive cancers. It is an antibody-drug conjugate that targets human epidermal growth factor receptor 2 (HER2). The drug comprises a humanized monoclonal antibody against HER2 conjugated to the cytotoxic agent monomethyl auristatin E (MMAE). Disitamab vedotin is indicated for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma and locally advanced or metastatic esophageal squamous cell carcinoma. It has 100 trials and 136 publications. The commercial significance of disitamab vedotin is its ability to target HER2-positive cancers. Pfizer Inc. is the company behind this marketed drug.","brandName":"Disitamab vedotin","ecosystem":[],"isGeneric":true,"mechanism":{"target":"human epidermal growth factor receptor 2 (HER2)","novelty":"best-in-class","modality":"monoclonal antibody","drugClass":"antibody-drug conjugate","explanation":"","oneSentence":"","technicalDetail":"Disitamab vedotin is a humanized monoclonal antibody against HER2 conjugated via a cleavable linker to the cytotoxic agent MMAE. The mechanism of action involves the antibody binding to HER2, followed by internalization and release of MMAE, which causes cell death. This targeted approach allows for selective killing of cancer cells while sparing healthy cells."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"_wikipedia":{"title":"Disitamab vedotin","extract":"Disitamab vedotin is an antibody-drug conjugate (ADC) developed by RemeGen for the treatment of various HER2-positive cancers. It comprises a humanized monoclonal antibody against human epidermal growth factor receptor 2 (HER2) conjugated via a cleavable linker to the cytotoxic agent monomethyl auristatin E (MMAE)."},"commercial":{"annualCostUS":"","genericStatus":"Biologic — patent protected","currentRevenue":"","patientPopulation":"","peakSalesEstimate":""},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=disitamab-vedotin","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=disitamab-vedotin","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":4,"url":"https://en.wikipedia.org/wiki/disitamab-vedotin","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://open.fda.gov/apis/drug/event/","fields":["safetySignals"],"source":"FDA 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