Application Nr Approved Date Route Status External Links
NDA208772 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Alunbrig Is Indicated For The Treatment Of Patients With Anaplastic Lymphoma Kinase (Alk)-Positive Metastatic Non-Small Cell Lung Cancer (Nsclc) Who Have Progressed On Or Are Intolerant To Crizotinib. This Indication Is Approved Under Accelerated Approval Based On Tumor 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 A Confirmatory Trial. Alunbrig Is A Kinase Inhibitor Indicated For The Treatment Of Patients With Anaplastic Lymphoma Kinase (Alk)-Positive Metastatic Non-Small Cell Lung Cancer (Nsclc) Who Have Progressed On Or Are Intolerant To Crizotinib. 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. Brigatinib

Comments