{"id":"herceptin-hylecta","safety":{"commonSideEffects":[{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Cardiotoxicity/left ventricular dysfunction"},{"rate":null,"effect":"Neuropathy"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Diarrhea"}]},"_chembl":null,"_dailymed":{"setId":"ebf30894-41cf-480c-8bc3-56f592a13813","title":"HERCEPTIN HYLECTA (TRASTUZUMAB AND HYALURONIDASE-OYSK) INJECTION, SOLUTION [GENENTECH, INC.]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Trastuzumab is a monoclonal antibody that targets human epidermal growth factor receptor 2 (HER2), which is overexpressed in certain breast and gastric cancers. By binding to HER2, it prevents ligand-independent signaling and recruits immune cells to destroy cancer cells through antibody-dependent cellular cytotoxicity (ADCC). Hylecta is a subcutaneous formulation designed to improve patient convenience compared to intravenous administration.","oneSentence":"Herceptin Hylecta is a subcutaneous formulation of trastuzumab that binds to HER2 receptors on cancer cells to block growth signaling and trigger immune-mediated cell death.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T06:05:24.362Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HER2-positive early breast cancer (adjuvant and neoadjuvant treatment)"},{"name":"HER2-positive metastatic breast cancer"},{"name":"HER2-positive gastric or gastroesophageal junction adenocarcinoma"}]},"trialDetails":[{"nctId":"NCT02693535","phase":"PHASE2","title":"TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer","status":"RECRUITING","sponsor":"American Society of Clinical Oncology","startDate":"2016-03-14","conditions":"Lymphoma, Non-Hodgkin, Multiple Myeloma, Advanced Solid Tumors","enrollment":4200},{"nctId":"NCT07299955","phase":"PHASE1","title":"A Phase 1 Comparative Study to Evaluate Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® After a Single 600 mg SC Injection in Healthy Male Volunteers","status":"NOT_YET_RECRUITING","sponsor":"Biocon Biologics UK PLC","startDate":"2026-01-09","conditions":"Healthy Male Participants","enrollment":150}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":4,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Herceptin Hylecta®","genericName":"Herceptin Hylecta®","companyName":"Biocon Biologics UK PLC","companyId":"biocon-biologics-uk-plc","modality":"Biologic","firstApprovalDate":"","aiSummary":"Herceptin Hylecta is a subcutaneous formulation of trastuzumab that binds to HER2 receptors on cancer cells to block growth signaling and trigger immune-mediated cell death. Used for HER2-positive early breast cancer (adjuvant and neoadjuvant treatment), HER2-positive metastatic breast cancer, HER2-positive gastric or gastroesophageal junction adenocarcinoma.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}