Application Nr Approved Date Route Status External Links
NDA210868 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Lorbrena ® Is Indicated For The Treatment Of Patients With Anaplastic Lymphoma Kinase (Alk)-Positive Metastatic Non-Small Cell Lung Cancer (Nsclc) Whose Disease Has Progressed On Crizotinib And At Least One Other Alk Inhibitor For Metastatic Disease; Or Alectinib As The First Alk Inhibitor Therapy For Metastatic Disease; Or Ceritinib As The First Alk Inhibitor Therapy For Metastatic Disease. This Indication Is Approved Under Accelerated Approval Based On Tumor Response Rate And Duration Of Response [See Clinical Studies (14.1) ] . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In A Confirmatory Trial. Lorbrena Is A Kinase Inhibitor Indicated For The Treatment Of Patients With Anaplastic Lymphoma Kinase (Alk)-Positive Metastatic Non-Small Cell Lung Cancer (Nsclc) Whose Disease Has Progressed On Crizotinib And At Least One Other Alk Inhibitor For Metastatic Disease; Or Alectinib As The First Alk Inhibitor Therapy For Metastatic Disease; Or Ceritinib As The First Alk Inhibitor Therapy For Metastatic Disease. This Indication Is Approved Under Accelerated Approval Based On Tumor Response Rate And Duration Of Response. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In A Confirmatory Trial. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Lorlatinib

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