{"id":"eu-authorized-nivolumab","safety":{"commonSideEffects":[{"rate":"30–40","effect":"Fatigue"},{"rate":"20–30","effect":"Diarrhea"},{"rate":"15–25","effect":"Nausea"},{"rate":"15–25","effect":"Rash"},{"rate":"15–20","effect":"Pruritus"},{"rate":"3–5","effect":"Immune-mediated pneumonitis"},{"rate":"2–5","effect":"Immune-mediated hepatitis"},{"rate":"2–4","effect":"Immune-mediated colitis"},{"rate":"5–10","effect":"Immune-mediated endocrinopathy (thyroiditis, adrenalitis)"}]},"_chembl":{"chemblId":"CHEMBL2108738","moleculeType":"Antibody"},"_fixedAt":"2026-03-30T16:03:15.039471","_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Nivolumab binds to programmed death receptor-1 (PD-1) on the surface of T cells, blocking interaction with its ligands (PD-L1 and PD-L2) expressed on tumor cells and immune cells. This blockade restores T-cell activation, proliferation, and anti-tumor immune response. By releasing the 'brakes' on the immune system, nivolumab enables the body's own T cells to recognize and destroy cancer cells.","oneSentence":"Nivolumab is a monoclonal antibody that blocks PD-1 on T cells, preventing tumor cells from evading immune attack.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:11:47.350Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Metastatic melanoma"},{"name":"Non-small cell lung cancer (NSCLC)"},{"name":"Renal cell carcinoma (RCC)"},{"name":"Classical Hodgkin lymphoma"},{"name":"Squamous cell carcinoma of the head and neck"},{"name":"Colorectal cancer (microsatellite instability-high or mismatch repair deficient)"},{"name":"Gastric cancer"},{"name":"Hepatocellular carcinoma"},{"name":"Mesothelioma"}]},"_fixedFields":["modality→Monoclonal Antibody"],"trialDetails":[{"nctId":"NCT05907122","phase":"PHASE3","title":"A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma","status":"COMPLETED","sponsor":"Amgen","startDate":"2023-07-26","conditions":"Melanoma","enrollment":256},{"nctId":"NCT06587451","phase":"PHASE3","title":"Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy®","status":"TERMINATED","sponsor":"Sandoz","startDate":"2024-12-19","conditions":"Melanoma","enrollment":52}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["OPDIVO®"],"phase":"phase_3","status":"active","brandName":"EU-authorized Nivolumab","genericName":"EU-authorized Nivolumab","companyName":"Amgen","companyId":"amgen","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Nivolumab is a monoclonal antibody that blocks PD-1 on T cells, preventing tumor cells from evading immune attack. Used for Metastatic melanoma, Non-small cell lung cancer (NSCLC), Renal cell carcinoma (RCC).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}