{"id":"gefitinib-mono-therapy","safety":{"commonSideEffects":[{"rate":"37-43%","effect":"Rash/acneiform dermatitis"},{"rate":"18-48%","effect":"Diarrhea"},{"rate":"13-18%","effect":"Nausea"},{"rate":"9-13%","effect":"Vomiting"},{"rate":"16-23%","effect":"Anorexia"},{"rate":"8-19%","effect":"Asthenia/fatigue"},{"rate":"0.3-1.5%","effect":"Interstitial lung disease"}]},"_chembl":{"chemblId":"CHEMBL939","moleculeType":"Small molecule","molecularWeight":"446.91"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Gefitinib binds to the ATP-binding pocket of EGFR and prevents autophosphorylation of the receptor, thereby blocking downstream signaling pathways (PI3K/Akt and MAPK/ERK) that drive cell growth and survival. This mechanism is particularly effective in tumors with activating EGFR mutations, which are common in non-small cell lung cancer, especially in Asian populations and never-smokers.","oneSentence":"Gefitinib is a tyrosine kinase inhibitor that selectively blocks epidermal growth factor receptor (EGFR) signaling to inhibit cancer cell proliferation.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:13:46.534Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-small cell lung cancer (NSCLC) with EGFR mutations"},{"name":"Advanced or metastatic NSCLC as first-line monotherapy"}]},"trialDetails":[{"nctId":"NCT01951469","phase":"PHASE3","title":"Gefitinib With or Without Chemotherapy in Brain Metastases From Non-small Cell Lung Cancer","status":"UNKNOWN","sponsor":"Sun Yat-sen University","startDate":"2016-01","conditions":"Non-small Cell Lung Cancer, Brain Metastases, EGFR Mutation","enrollment":160},{"nctId":"NCT01498562","phase":"PHASE2","title":"Phase II Study of Gefitinib Plus Nimotuzumab Versus Gefitinib in Non-small Cell Lung Cancer","status":"COMPLETED","sponsor":"Yonsei University","startDate":"2011-12","conditions":"Non Small Cell Lung Cancer (NSCLC)","enrollment":160}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Gefitinib mono-therapy","genericName":"Gefitinib mono-therapy","companyName":"Sun Yat-sen University","companyId":"sun-yat-sen-university","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Gefitinib is a tyrosine kinase inhibitor that selectively blocks epidermal growth factor receptor (EGFR) signaling to inhibit cancer cell proliferation. Used for Non-small cell lung cancer (NSCLC) with EGFR mutations, Advanced or metastatic NSCLC as first-line monotherapy.","enrichmentLevel":3,"visitCount":2,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}