{"id":"dacomitinib-hydrate","rwe":[],"tags":[],"phase":"preclinical","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT04155541"],"aliases":[],"patents":[],"pricing":[],"allNames":"dacomitinib hydrate","offLabel":[],"timeline":[],"aiSummary":"Dacomitinib hydrate is an irreversible pan-HER tyrosine kinase inhibitor approved for first-line treatment of metastatic non-small cell lung cancer with EGFR mutations. It blocks multiple growth signals (EGFR, HER2, HER4) more comprehensively than reversible inhibitors, potentially overcoming resistance mechanisms and offering improved progression-free survival.","brandName":"dacomitinib hydrate","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"Cyclin-G-associated kinase, Receptor-interacting serine/threonine-protein kinase 2, Receptor-interacting serine/threonine-protein kinase 3","novelty":"","modality":"","drugClass":"The usual adult starting dosage for oral use is 45mg of dacomitinib hydrate once daily. The dose sho","explanation":"Dacomitinib works by permanently disabling a family of proteins called HER receptors that sit on the surface of lung cancer cells. These receptors normally receive growth signals from the body, telling the cancer cells to multiply. By locking onto and permanently inactivating these receptors—particularly EGFR, HER2, and HER4—dacomitinib cuts off the cancer cell's ability to receive these growth commands.\n\nWhat makes dacomitinib different from some earlier drugs is that it targets multiple receptors in the HER family simultaneously and binds irreversibly, meaning once it attaches to a receptor, it doesn't let go. This comprehensive blocking approach makes it harder for cancer cells to develop workarounds or resistance. It's specifically effective in lung cancers that have mutations in the EGFR gene, which makes those cancer cells especially dependent on this signaling pathway for survival.\n\nThe drug is given as a daily pill and works best in patients whose tumors have these specific EGFR mutations, as they rely heavily on this pathway. By shutting down multiple related growth signals at once and doing so permanently, dacomitinib can stop the cancer from growing and spreading more effectively than drugs that only block one receptor or bind reversibly.","oneSentence":"The usual adult starting dosage for oral use is 45mg of dacomitinib hydrate once daily. The dose sho","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"genericName":"dacomitinib-hydrate","indications":{"approved":[{"name":"EGFR mutation-positive, unresectable or recurrent non-small cell lung cancer","diseaseId":"egfr-mutation-positive-unresectable-or-recurrent-non-small-cell-lung-cancer","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Non-small cell lung cancer, positive for epidermal growth factor receptor expression","diseaseId":"non-small-cell-lung-cancer-positive-for-epidermal-growth-factor-receptor-expression","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[{"name":"EGFR Mutation-positive Inoperable or Reccrent NSCLC","phase":"preclinical","trialId":"","patients":null,"diseaseId":"oncology","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04155541","phase":"N/A","title":"Special Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of ","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":40,"indication":"EGFR Mutation-positive Inoperable or Reccrent NSCLC","completionDate":"2025-04","primaryEndpoint":"Secondary data collection study: safety and efficacy of VIZIMPRO under Japanese medical practice"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"crossReferences":{"chemblId":"CHEMBL2105719"},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"","enrichmentLevel":3,"visitCount":4,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}