BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) are oral kinase inhibitors used in combination for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. BRAFTOVI targets the BRAF protein, while MEKTOVI targets the MEK protein, both of which are part of the MAPK signaling pathway involved in cell growth. The combination of these drugs has also been approved for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation and for metastatic colorectal cancer (CRC) with a BRAF V600E mutation, when used in combination with cetuximab. These approvals are based on the positive results from clinical trials such as the COLUMBUS and BEACON CRC studies, which demonstrated significant improvements in progression-free survival and overall survival. The combination therapy aims to provide a more effective and personalized treatment option for patients with these specific genetic mutations.
Metastatic melanoma is an advanced form of skin cancer where the melanoma cells have spread from the original tumor site to other parts of the body, such as the lungs, liver, brain, or bones. This occurs when melanoma cells penetrate the deeper layers of the skin and enter the lymphatic system or bloodstream, allowing them to travel and form secondary tumors. Metastatic melanoma is particularly aggressive and challenging to treat, with symptoms varying widely depending on the organs affected. Common signs include new lumps under the skin, unexplained weight loss, fatigue, and changes in vision or neurological functions if the brain is involved. Treatment options have expanded significantly in recent years, including targeted therapies, immunotherapies, and combination treatments, which have improved survival rates and quality of life for many patients.
Companion diagnostic testing is essential in the treatment of metastatic melanoma with BRAFTOVI (encorafenib) and MEKTOVI (binimetinib). These targeted therapies are specifically effective for patients whose tumors harbor the BRAF V600E or V600K mutations. A companion diagnostic test, approved by the FDA, identifies these genetic mutations in the melanoma cells. This genetic profiling ensures that only patients with the specific BRAF mutations receive BRAFTOVI and MEKTOVI, optimizing treatment efficacy and minimizing unnecessary exposure to ineffective therapies. By accurately selecting patients who are most likely to benefit from these drugs, companion diagnostic testing plays a pivotal role in personalized cancer treatment, enhancing both the safety and effectiveness of the therapy.
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.
At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of patients with cancer. Our robust pipeline is focused on exploring the potential of innovative therapies to address significant unmet medical needs and to improve outcomes for cancer patients worldwide. With a portfolio of more than 20 approved cancer medicines and biosimilars, and a deep pipeline of investigational drugs, we aim to transform the cancer treatment landscape and redefine life with cancer. For more information, visit Pfizer.
