TAFINLAR is a BRAF inhibitor that targets and inhibits the activity of the mutated BRAF protein, which is involved in the growth and spread of cancer cells. It is approved for the treatment of patients with BRAF V600E mutation-positive unresectable or metastatic melanoma, and in combination with MEKINIST (trametinib) for the treatment of BRAF V600E mutation-positive metastatic non-small cell lung cancer (NSCLC) and anaplastic thyroid cancer (ATC). The safety and efficacy of TAFINLAR have been demonstrated in various clinical trials, making it a critical option for patients with these specific genetic mutations.
Melanoma is a type of cancer that develops 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 occur anywhere on the body, including areas not typically exposed to sunlight. Melanoma is characterized by the uncontrolled growth of melanocytes, which can form malignant tumors. Key risk factors include excessive UV exposure, fair skin, a history of sunburns, and genetic predisposition. If detected early, melanoma is highly treatable, but it can spread to other parts of the body, making it more challenging to treat in advanced stages. Treatments typically include surgery, radiation, chemotherapy, and targeted therapies such as BRAF and MEK inhibitors for specific genetic mutations.
Companion diagnostic testing is crucial in determining the appropriateness of prescribing TAFINLAR (dabrafenib) for the treatment of melanoma. TAFINLAR is specifically indicated for patients with unresectable or metastatic melanoma who have a BRAF V600E mutation. This genetic mutation leads to an abnormal version of the BRAF protein that promotes cancer cell growth.
FDA-approved companion diagnostic tests, such as the THxID BRAF kit, are used to detect the presence of BRAF V600E mutations in tumor tissue. These tests ensure that TAFINLAR is prescribed only to patients who are likely to benefit from the treatment, thereby optimizing its efficacy and minimizing unnecessary exposure to the drug for those without the mutation. By confirming the presence of the BRAF V600E mutation, healthcare providers can personalize treatment plans and improve outcomes for patients with this specific type of melanoma.
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.
TAFINLAR (dabrafenib) is a targeted therapy that inhibits the activity of the mutated BRAF protein, which is involved in the growth and spread of melanoma cells. By blocking the BRAF V600E mutation, TAFINLAR helps to slow down or stop the growth of melanoma cells, making it an effective treatment for patients with this specific genetic alteration.
TAFINLAR is approved for patients with unresectable or metastatic melanoma who have tested positive for the BRAF V600E mutation. Eligibility is determined through FDA-approved companion diagnostic tests, such as the THxID BRAF kit, which identify the presence of the mutation in tumor tissue.
Common side effects of TAFINLAR include fever, fatigue, nausea, headache, skin rash, joint pain, and vomiting. More serious side effects can include secondary skin cancers, severe skin reactions, hyperglycemia (high blood sugar), and eye problems. Patients should discuss potential side effects with their healthcare provider to understand the risks and how to manage them.
TAFINLAR is administered orally in the form of capsules. The typical dosage for adults is 150 mg taken twice daily, either one hour before or two hours after a meal. 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, TAFINLAR is often used in combination with MEKINIST (trametinib) for the treatment of BRAF V600E mutation-positive unresectable or metastatic melanoma. This combination has been shown to improve treatment outcomes compared to using 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 TAFINLAR. These tests detect the presence of BRAF V600E 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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