Trametinib

(Mekinist®)

Trametinib

Drug updated on 11/13/2023

Dosage FormTablet (oral; 0.5 mg, 2 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.

Product Monograph / Prescribing Information

Document TitleYearSource
Mekinist (trametinib) Prescribing Information.2023Novartis Pharmaceuticals Corporation, East Hanover, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Neoadjuvant treatment for stage III and IV cutaneous melanoma.2023Cochrane Database of Systematic Reviews
Impact of immune checkpoint inhibitors and targeted therapy on health-related quality of life of people with stage III and IV melanoma: a mixed-methods systematic review. 2023European Journal of Cancer
Acceptability of drugs in the treatment of unresectable/metastatic BRAF V600-mutant melanoma: a systematic review and network meta-analysis.2022Frontiers in Oncology
Comparative efficacy and safety of targeted therapies for BRAF-mutant unresectable or metastatic melanoma: results from a systematic literature review and a network meta-analysis.2022Cancer Treatment Reviews
Efficacy and Safety of Trametinib in Neurofibromatosis Type 1-Associated Plexiform Neurofibroma and Low-Grade Glioma: A Systematic Review and Meta-Analysis. 2022Pharmaceuticals
Adjuvant Treatments of Adult Melanoma: A Systematic Review and Network Meta-Analysis. 2022Frontiers in Oncology
Sensitivity to dabrafenib and trametinib treatments in patients with non-small-cell cancer harboring BRAF compound mutations: A pooled analysis of BRAF p.V600E-positive advanced non-small-cell lung cancer. 2022Cancer Genetics
Novel “T-Dimension” Therapies for Pediatric Optic Pathway Glioma: A Timely, Targeted, and Tailored Treatment Trend. 2022Pediatric Neurosurgery
Clinical guidance report: dabrafenib (Tafinlar) in combination with trametinib (Mekinist).2021CADTH
Comparative efficacy and safety of adjuvant nivolumab versus other treatments in adults with resected melanoma: a systematic literature review and network meta-analysis.2021BMC Cancer
Adjuvant therapy of high-risk (stages IIC-IV) malignant melanoma in the post interferon-alpha era: a systematic review and meta-analysis.2021Frontiers in Oncology
Comparative efficacy of dabrafenib + trametinib versus treatment options for metastatic melanoma in first-line settings.2021Journal of Comparative Effectiveness Research
Economic evaluation of systemic treatments for advanced melanoma: a systematic review.2020Value Health
Efficacy and safety of dabrafenib-trametinib in the treatment of unresectable or metastatic melanoma with BRAF V600 mutation: a systematic review and network meta-analysis. 2020Dermatologic Therapy
Final clinical guidance report: dabrafenib and trametinib (Tafinlar and Mekinist) for melanoma adjuvant therapy. 2019CADTH
Network indirect comparison of 3 BRAF + MEK inhibitors for the treatment of advanced BRAF mutated melanoma. 2019Clinical and Translational Oncology
A systematic literature review and network meta-analysis of effectiveness and safety outcomes in advanced melanoma. 2019European Journal of Cancer
Efficacy and adverse events in metastatic melanoma patients treated with combination BRAF plus MEK inhibitors versus BRAF inhibitors: a systematic review.2019Cancers
Network meta-analysis of therapies for previously untreated advanced BRAF-mutated melanoma. 2019Cancer Treatment Reviews
A Systematic Review of Phase II Targeted Therapy Clinical Trials in Anaplastic Thyroid Cancer. 2019Cancers
How to MEK the best of uveal melanoma: a systematic review on the efficacy and safety of MEK inhibitors in metastatic or unresectable uveal melanoma. 2018European Journal of Cancer
Comparative Efficacy of Treatments for Previously Treated Advanced or Metastatic Non-Small-Cell Lung Cancer: A Network Meta-Analysis.2018Advances in Therapy

Clinical Practice Guidelines