Mekinist FDA Approval History
Last updated by Judith Stewart, BPharm on March 29, 2023.
FDA Approved: Yes (First approved May 29, 2013)
Brand name: Mekinist
Generic name: trametinib
Dosage form: Tablets and Oral Solution
Company: Novartis Pharmaceuticals Corporation
Treatment for: Melanoma, Metastatic, Non-Small Cell Lung Cancer, Thyroid Cancer, Solid Tumors, Low-Grade Glioma
Mekinist (trametinib) is a kinase inhibitor for the treatment of melanoma, non-small cell lung cancer, thyroid cancer, solid tumors, and low-grade glioma with BRAF V600 mutations.
Mekinist (trametinib) is an inhibitor of some mutated BRAF kinases, including the BRAF V600E and V600K mutations.
Mekinist is 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.
- in combination with dabrafenib (Tafinlar) for:
- the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
- 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.
- the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.
- the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.
- the treatment of adult and pediatric patients 6 years 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).
- 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.
- Mekinist tablets and oral solution are taken orally once daily least 1 hour before or at least 2 hours after a meal.
- Warnings and precautions associated with Mekinist include new primary malignancies, hemorrhage, colitis and gastrointestinal perforation, venous thromboembolism, cardiomyopathy, ocular toxicities, interstitial lung disease (ILD), serious febrile reactions, serious skin toxicities, hyperglycemia, and embryo-fetal toxicity.
- Common adverse reactions for Mekinist as a single agent include rash, diarrhea, and lymphedema.
Common adverse reactions for Mekinist with dabrafenib include:- Unresectable or metastatic melanoma: pyrexia, nausea, rash, chills, diarrhea, vomiting, hypertension, and peripheral edema.
- Adjuvant treatment of melanoma: pyrexia, fatigue, nausea, headache, rash, chills, diarrhea, vomiting, arthralgia, and myalgia.
- NSCLC: pyrexia, fatigue, nausea, vomiting, diarrhea, dry skin, decreased appetite, edema, rash, chills, hemorrhage, cough, and dyspnea.
- Adult patients with solid tumors: pyrexia, fatigue, nausea, rash, chills, headache, hemorrhage, cough, vomiting, constipation, diarrhea, myalgia, arthralgia, and edema.
- Pediatric patients with solid tumors: pyrexia, rash, vomiting, fatigue, dry skin, cough, diarrhea, dermatitis acneiform, headache, abdominal pain, nausea, hemorrhage, constipation, and paronychia.
- Pediatric patients with LGG: pyrexia, rash, headache, vomiting, musculoskeletal pain, fatigue, diarrhea, dry skin, nausea, hemorrhage, abdominal pain and dermatitis acneiform.
Development timeline for Mekinist
Further information
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