Braftovi

Product manufactured by Array Biopharma Inc.

Application Nr Approved Date Route Status External Links
NDA210496 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Braftovi Is A Kinase Inhibitor Indicated: In Combination With Binimetinib, For The Treatment Of Patients With Unresectable Or Metastatic Melanoma With A Braf V600e Or V600k Mutation, As Detected By An Fda-Approved Test. ( 1.1 , 2.1 ) In Combination With Cetuximab, For The Treatment Of Adult Patients With Metastatic Colorectal Cancer (Crc) With A Braf V600e Mutation, As Detected By An Fda-Approved Test, After Prior Therapy. ( 1.2 , 2.1 ) Limitations Of Use Braftovi Is Not Indicated For Treatment Of Patients With Wild-Type Braf Melanoma Or Wild-Type Braf Crc. ( 1.3 , 5.2 ) 1.1 Braf V600e Or V600k Mutation-Positive Unresectable Or Metastatic Melanoma Braftovi ® Is Indicated, In Combination With Binimetinib, For The Treatment Of Patients With Unresectable Or Metastatic Melanoma With A Braf V600e Or V600k Mutation, As Detected By An Fda-Approved Test [See Dosage And Administration (2.1) ] . 1.2 Braf V600e Mutation-Positive Metastatic Colorectal Cancer (Crc) Braftovi Is Indicated, In Combination With Cetuximab, For The Treatment Of Adult Patients With Metastatic Colorectal Cancer (Crc) With A Braf V600e Mutation, As Detected By An Fda-Approved Test, After Prior Therapy [See Dosage And Administration (2.1) ] . 1.3 Limitations Of Use Braftovi Is Not Indicated For Treatment Of Patients With Wild-Type Braf Melanoma Or Wild-Type Braf Crc [See Warnings And Precautions (5.2) ] .

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Encorafenib ENCORAFENIB ZINC68249103

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