Indications of Trametinib

1.BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma

Trametinib 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.

2.Adjuvant Treatment of BRAF V600E or V600K Mutation-Positive Melanoma

Trametinib 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.

3.BRAF V600E Mutation-Positive Metastatic NSCLC

Trametinib 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. 

4.BRAF V600E Mutation-Positive Locally Advanced or Metastatic Anaplastic Thyroid Cancer

Trametinib 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.

5.BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors

Trametinib is indicated, in combination with dabrafenib, for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall 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(s).

6.BRAF V600E Mutation-Positive Low-Grade Glioma

Trametinib is indicated, in combination with dabrafenib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.

7.Limitations of Use

Trametinib is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition.

from FDA，2024.03