BRAFTOVI (encorafenib) is an oral small molecule kinase inhibitor that targets the BRAF V600E mutation, which is involved in the MAPK signaling pathway implicated in various cancers, including colorectal cancer. Cetuximab (ERBITUX®) is an epidermal growth factor receptor (EGFR) inhibitor. The combination of BRAFTOVI and cetuximab is FDA-approved for the treatment of adult patients with metastatic colorectal cancer (CRC) harboring the BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. This approval was based on results from the Phase 3 BEACON CRC trial, which demonstrated significant improvements in overall survival and progression-free survival for patients treated with this combination compared to standard treatments. Pfizer holds exclusive rights to BRAFTOVI in the U.S. and Canada, with additional commercialization rights held by partners in other regions.
Metastatic colorectal cancer (mCRC) is an advanced stage of colorectal cancer where the cancer cells have spread from the original site in the colon or rectum to other parts of the body, such as the liver, lungs, or peritoneum. This dissemination occurs through the bloodstream or lymphatic system, making the disease more complex and challenging to treat. Common symptoms of mCRC include changes in bowel habits, blood in the stool, unexplained weight loss, and abdominal pain. Treatment options typically involve a combination of surgery, chemotherapy, targeted therapies, and immunotherapy, depending on the location and extent of the metastases, as well as the patient’s overall health. Early detection and a personalized treatment approach are crucial for improving outcomes and managing the disease effectively.
Companion diagnostic testing is essential for prescribing BRAFTOVI® (encorafenib) in combination with cetuximab for the treatment of metastatic colorectal cancer (mCRC). This testing identifies the presence of the BRAF V600E mutation in the tumor cells, which is a critical factor in determining the suitability of this targeted therapy. The BRAF V600E mutation leads to the activation of the MAPK signaling pathway, promoting cancer cell growth and survival. By confirming the presence of this specific mutation through an FDA-approved test, healthcare providers can ensure that only patients who are likely to benefit from BRAFTOVI and cetuximab receive the treatment. This precision medicine approach enhances the effectiveness of the therapy, improves patient outcomes, and avoids unnecessary side effects in patients who do not have the mutation. The use of companion diagnostics thus enables a more personalized and targeted treatment strategy for patients with mCRC.
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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.
BRAFTOVI (encorafenib) in combination with cetuximab is used for the treatment of adult patients with metastatic colorectal cancer (mCRC) that harbors a BRAF V600E mutation. This combination therapy is specifically indicated for patients who have received prior treatment. The combination targets the BRAF mutation, which plays a crucial role in the growth and survival of cancer cells.
BRAFTOVI is a BRAF kinase inhibitor that targets the mutated BRAF V600E protein, inhibiting its activity and thereby blocking the MAPK signaling pathway involved in cancer cell growth. Cetuximab, an EGFR inhibitor, works by blocking the epidermal growth factor receptor, which also plays a role in cell proliferation. Together, these drugs effectively target and inhibit pathways critical for the survival of BRAF V600E-mutant colorectal cancer cells.
Patients with metastatic colorectal cancer who have the BRAF V600E mutation and have previously undergone treatment are eligible for this combination therapy. It is essential that the presence of the BRAF V600E mutation is confirmed through an FDA-approved companion diagnostic test before initiating treatment.
Companion diagnostic testing identifies the BRAF V600E mutation in colorectal cancer cells, which is necessary to determine a patient’s eligibility for treatment with BRAFTOVI and cetuximab. This ensures that only patients with the specific mutation, which the therapy targets, receive the treatment, optimizing its effectiveness and avoiding unnecessary exposure to the drugs for those who would not benefit.
Common side effects include fatigue, nausea, diarrhea, skin rash, abdominal pain, and musculoskeletal pain. Serious side effects can also occur, such as new primary malignancies, cardiomyopathy, and severe dermatologic reactions. Patients should discuss potential side effects with their healthcare provider and be closely monitored during treatment.
Patients should consult with their oncologist to determine if BRAFTOVI and cetuximab are suitable for their treatment. The healthcare provider will perform necessary diagnostic tests to confirm the BRAF V600E mutation and guide the patient through the process of accessing these medications, including managing insurance coverage and support programs offered by Pfizer.
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.
Eli Lilly and Company, headquartered in Indianapolis, Indiana, is a global healthcare and biopharmaceutical company committed to making life better through the development of innovative medicines. With a nearly 150-year history, Lilly has pioneered advancements in healthcare, including the development of insulin and treatments for various diseases like COVID-19. The company focuses on long-term investments in research and development to address significant health challenges worldwide.
Lilly operates several manufacturing sites in the United States, including new facilities in North Carolina, which will enhance their capacity to produce injectable medicines and devices. The company plans to invest $1 billion in a new pharmaceutical manufacturing facility in Concord, NC, creating nearly 600 jobs. This expansion demonstrates Lilly’s commitment to growth and its collaboration with local communities and educational institutions to strengthen its workforce and production capabilities.
