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Trametinib

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1 INDICATIONS AND USAGE
1.1 BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma 
MEKINIST® is indicated, as a single agent 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 Clinical Studies (14.1)].

1.2 BRAF V600E Mutation-Positive Metastatic NSCLC 
MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with metastatic nonsmall cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test [see Clinical Studies (14.2)].

2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
 - Melanoma
Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of treatment with MEKINIST and dabrafenib [see Clinical Studies (14.1)]. Information on FDA-approved tests for the detection of BRAF V600 mutations in melanoma is available at: 
http://www.fda.gov/CompanionDiagnostics.
 - NSCLC
Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with MEKINIST and dabrafenib [see Clinical Studies (14.2)]. Information on FDA-approved tests for the detection of BRAF V600E mutations in NSCLC is available at: 
http://www.fda.gov/CompanionDiagnostics.

14 NONCLINICAL TOXICOLOGY
14.1 BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma
 - MEKINIST with Dabrafenib
All patients had tumor containing BRAF V600E or V600K mutations as determined by centralized testing with the FDA-approved companion diagnostic test; 85% had BRAF V600E mutation-positive melanoma and 15% had BRAF V600K mutation-positive melanoma.

14.2 BRAF V600E Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC)
In a subgroup analysis of patinets with retrospectively centrally confirmed BRAF V600E mutation-positive NSCLC with the Oncomine™ Dx Target Test, the ORR results were similar to those presented in Table 11.

17 PATIENT COUNSELING INFORMATION
 - Confirmation of BRAF V600E or V600K mutation 
Evidence of BRAF V600E or 600K mutation within the tumor specimen is necessary to identify patients for whom treatment with MEKINIST is indicated [see Dosage and Administration (2.1)].

Patinet Information
 - What is MEKINIST?
MEKINIST is a prescription medicine used alone or in combination with a medicine called dabrafenib to treat people with a type of skin cancer called melanoma that has a certain type of abnormal “BRAF” gene.

(2018.4.30 업데이트)