MEKINIST is a MEK inhibitor that blocks the activity of MEK1 and MEK2 proteins, which are involved in the signaling pathway that promotes cancer cell growth. It is approved as monotherapy and in combination with Tafinlar (dabrafenib) for the treatment of patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma, as well as for the treatment of BRAF V600E mutation-positive metastatic non-small cell lung cancer (NSCLC) and anaplastic thyroid cancer (ATC). MEKINIST is also approved for use in combination with Tafinlar for patients with BRAF V600E mutation-positive low-grade glioma in pediatric patients 1 year of age and older. The safety and efficacy of MEKINIST have been established through numerous clinical trials, and it continues to be a critical option for patients with these specific genetic mutations.
Melanoma is a type of skin cancer that originates in the melanocytes, the cells responsible for producing melanin, the pigment that gives skin its color. It is the most serious form of skin cancer and can develop anywhere on the body, but it is most commonly found on areas exposed to the sun, such as the back, legs, arms, and face. Key risk factors include excessive UV exposure, fair skin, a history of sunburns, and genetic predisposition. Melanoma can spread to other parts of the body if not detected and treated early, making early diagnosis and treatment crucial. Treatment options include surgery, radiation, chemotherapy, targeted therapy, and immunotherapy, depending on the stage and characteristics of the cancer.
Companion diagnostic testing is critical in determining the appropriateness of prescribing MEKINIST (trametinib) for the treatment of melanoma. Specifically, MEKINIST is indicated for patients with unresectable or metastatic melanoma that harbors BRAF V600E or V600K mutations. The presence of these mutations is identified using FDA-approved companion diagnostic tests, such as the THxID BRAF test developed by bioMérieux.
These tests detect the BRAF V600E and V600K mutations, ensuring that MEKINIST is administered to patients most likely to benefit from the therapy. This targeted approach not only optimizes treatment efficacy but also minimizes unnecessary exposure to the drug for patients without these mutations. By confirming the genetic profile of the melanoma, companion diagnostic tests enable personalized treatment plans, enhancing patient outcomes and adhering to precision medicine principles.
Place a test order through your EMR system if enabled or order online by logging in or signing-up for a Foundation Medicine account. Orders can also be submitted via email or fax using our Test Requisition Form.
Order this test through your EHR if you have an interface with Labcorp, via Labcorp Link, or by paper requisition.
This companion diagnostic was developed by an IVD manufacturer as a kit. This is a valid FDA approved test if utilized by 3rd party diagnostic labs who have validated the test using the kit on the specified platform. It is not directly orderable from the manufacturer.
MEKINIST (trametinib) is a targeted therapy that inhibits MEK1 and MEK2 proteins, which are part of the MAPK/ERK signaling pathway. This pathway is often overactive in melanoma cells with BRAF V600E or V600K mutations, leading to uncontrolled cell growth. By blocking these proteins, MEKINIST helps slow down or stop the growth of melanoma cells.
MEKINIST is approved for patients with unresectable or metastatic melanoma that tests positive for the BRAF V600E or V600K mutations. Eligibility is determined through FDA-approved companion diagnostic tests, which identify these specific genetic mutations in tumor tissue.
Common side effects of MEKINIST include rash, diarrhea, fatigue, peripheral edema (swelling of the extremities), and skin reactions. More serious side effects can include cardiomyopathy (heart muscle disease), retinal vein occlusion (a blockage of the veins in the retina), and interstitial lung disease (lung inflammation). Patients should discuss potential side effects with their healthcare provider to understand the risks and how to manage them.
MEKINIST is administered orally as a tablet. The typical dosage for adults is 2 mg taken once daily, either with or without food. The exact dosage and treatment schedule will be determined by the healthcare provider based on the patient’s condition and response to the therapy.
Yes, MEKINIST is often used in combination with Tafinlar (dabrafenib) for the treatment of BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma. This combination has been shown to improve treatment outcomes compared to either drug alone. Patients should consult their oncologist to determine the most appropriate treatment plan.
Companion diagnostic tests are essential for identifying melanoma patients who are likely to benefit from MEKINIST. These tests detect the presence of BRAF V600E or V600K mutations in tumor samples, ensuring that the treatment is targeted and effective for those most likely to respond. By confirming the genetic profile of the melanoma, these tests help personalize the treatment plan, optimizing outcomes for patients.
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