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Molecular Profile ERBB2 over exp
Therapy Trastuzumab-anns
Indication/Tumor Type gastric adenocarcinoma
Response Type sensitive

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ERBB2 over exp gastric adenocarcinoma sensitive Trastuzumab-anns FDA approved - On Companion Diagnostic Actionable In a Phase I trial that supported FDA approval, the Herceptin (trastuzumab) biosimilar Kanjinti (Trastuzumab-anns) demonstrated structure, function, and pharmacokinetic profile comparable to Herceptin (trastuzumab) (PMID: 28341959), thus supporting the extrapolation of data from the Phase III trial that supported the approval of Herceptin (trastuzumab) in Erbb2 (Her2) overexpressing gastric adenocarcinoma (PMID: 20728210; NCT01041404) for approval of Kanjinti (Trastuzumab-anns) (FDA.gov). 20728210 28341959 detail... detail... detail...
PubMed Id Reference Title Details
FDA.gov Full reference...
(20728210) Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Full reference...
Full reference...
Kanjinti (Trastuzumab-anns) FDA Drug Label Full reference...
(28341959) A randomized, single-blind, single-dose study evaluating the pharmacokinetic equivalence of proposed biosimilar ABP 980 and trastuzumab in healthy male subjects. Full reference...