{"id":"eu-opdivo","safety":{"commonSideEffects":[{"rate":"30–40%","effect":"Fatigue"},{"rate":"20–30%","effect":"Nausea"},{"rate":"15–25%","effect":"Decreased appetite"},{"rate":"15–25%","effect":"Diarrhea"},{"rate":"3–5%","effect":"Immune-mediated pneumonitis"},{"rate":"2–5%","effect":"Immune-mediated hepatitis"},{"rate":"2–4%","effect":"Immune-mediated colitis"}]},"_chembl":{"chemblId":"CHEMBL5857501","moleculeType":null,"molecularWeight":"542.39"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"By inhibiting the PD-1 pathway, the drug removes a key immune checkpoint that tumors exploit to evade T cell-mediated killing. This allows cytotoxic T lymphocytes to recognize and attack cancer cells more effectively. The mechanism has demonstrated clinical benefit across multiple solid and hematologic malignancies.","oneSentence":"EU-Opdivo® is a PD-1 checkpoint inhibitor that blocks the interaction between PD-1 on T cells and PD-L1/PD-L2 on tumor cells, thereby restoring anti-tumor immune responses.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:11:47.746Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Metastatic non-small cell lung cancer"},{"name":"Melanoma"},{"name":"Renal cell carcinoma"},{"name":"Hodgkin lymphoma"},{"name":"Head and neck squamous cell carcinoma"}]},"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":"NCT07176650","phase":"PHASE1","title":"Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY®) As A First-Line Treatment For Patients With Unresectable Hepatocellular Carcinoma","status":"RECRUITING","sponsor":"Shanghai Henlius Biotech","startDate":"2025-11-25","conditions":"Hepatocellular Carcinoma (HCC)","enrollment":246},{"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},{"nctId":"NCT07221734","phase":"PHASE3","title":"Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma","status":"RECRUITING","sponsor":"mAbxience Research S.L.","startDate":"2025-12-29","conditions":"Advanced (Unresectable or Metastatic) Melanoma","enrollment":632},{"nctId":"NCT06841185","phase":"PHASE3","title":"A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX13 with YERVOY As a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma","status":"NOT_YET_RECRUITING","sponsor":"Shanghai Henlius Biotech","startDate":"2025-04-30","conditions":"Hepatocellular Carcinoma (HCC)","enrollment":656}],"_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":[],"phase":"phase_3","status":"active","brandName":"EU-Opdivo®","genericName":"EU-Opdivo®","companyName":"mAbxience Research S.L.","companyId":"mabxience-research-s-l","modality":"Small molecule","firstApprovalDate":"","aiSummary":"EU-Opdivo® is a PD-1 checkpoint inhibitor that blocks the interaction between PD-1 on T cells and PD-L1/PD-L2 on tumor cells, thereby restoring anti-tumor immune responses. Used for Metastatic non-small cell lung cancer, Melanoma, Renal cell carcinoma.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}