Application Nr Approved Date Route Status External Links
NDA213591 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Tabrecta Is Indicated For The Treatment Of Adult Patients With Metastatic Non-Small Cell Lung Cancer (Nsclc) Whose Tumors Have A Mutation That Leads To Mesenchymal-Epithelial Transition (Met) Exon 14 Skipping As Detected By An Fda-Approved Test. This Indication Is Approved Under Accelerated Approval Based On Overall Response Rate And Duration Of Response [See Clinical Studies (14)] . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trial(S). Tabrecta Is A Kinase Inhibitor Indicated For The Treatment Of Adult Patients With Metastatic Non-Small Cell Lung Cancer (Nsclc) Whose Tumors Have A Mutation That Leads To Mesenchymal-Epithelial Transition (Met) Exon 14 Skipping As Detected By An Fda-Approved Test. This Indication Is Approved Under Accelerated Approval Based On Overall Response Rate And Duration Of Response. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trial(S). ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Capmatinib

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