Application Nr Approved Date Route Status External Links
NDA204114 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Mekinist Is A Kinase Inhibitor Indicated As A Single Agent For The Treatment Of Braf-Inhibitor Treatment-Naïve Patients With Unresectable Or Metastatic Melanoma With Braf V600e Or V600k Mutations As Detected By An Fda-Approved Test. ( 1.1 , 2.1 ) Mekinist Is Indicated, In Combination With Dabrafenib, For: The Treatment Of Patients With Unresectable Or Metastatic Melanoma With Braf V600e Or V600k Mutations As Detected By An Fda-Approved Test. ( 1.1 , 2.1 ) The Adjuvant Treatment Of Patients With Melanoma With Braf V600e Or V600k Mutations, As Detected By An Fda-Approved Test, And Involvement Of Lymph Node(S), Following Complete Resection. ( 1.2 , 2.1 ) The Treatment Of Patients With Metastatic Non-Small Cell Lung Cancer (Nsclc) With Braf V600e Mutation As Detected By An Fda-Approved Test. ( 1.3 , 2.1 ) The Treatment Of Patients With Locally Advanced Or Metastatic Anaplastic Thyroid Cancer (Atc) With Braf V600e Mutation And With No Satisfactory Locoregional Treatment Options. ( 1.4 , 2.1 ) 1.1 Braf V600e Or V600k Mutation-Positive Unresectable Or Metastatic Melanoma Mekinist ® Is Indicated, As A Single Agent In Braf-Inhibitor Treatment-Naïve Patients Or In Combination With Dabrafenib, For The Treatment Of Patients With Unresectable Or Metastatic Melanoma With Braf V600e Or V600k Mutations, As Detected By An Fda-Approved Test [See Dosage And Administration (2.1)] . 1.2 Adjuvant Treatment Of Braf V600e Or V600k Mutation-Positive Melanoma Mekinist Is Indicated, In Combination With Dabrafenib, For The Adjuvant Treatment Of Patients With Melanoma With Braf V600e Or V600k Mutations As Detected By An Fda-Approved Test, And Involvement Of Lymph Node(S), Following Complete Resection [See Dosage And Administration (2.1)]. 1.3 Braf V600e Mutation-Positive Metastatic Nsclc Mekinist Is Indicated, In Combination With Dabrafenib, For The Treatment Of Patients With Metastatic Non-Small Cell Lung Cancer (Nsclc) With Braf V600e Mutation As Detected By An Fda-Approved Test [See Dosage And Administration (2.1)] . 1.4 Braf V600e Mutation-Positive Locally Advanced Or Metastatic Anaplastic Thyroid Cancer Mekinist Is Indicated, In Combination With Dabrafenib, For The Treatment Of Patients With Locally Advanced Or Metastatic Anaplastic Thyroid Cancer (Atc) With Braf V600e Mutation And With No Satisfactory Locoregional Treatment Options [See Dosage And Administration (2.1)] .

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Trametinib Dimethyl Sulfoxide TRAMETINIB DIMETHYL SULFOXIDE ZINC43100709

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