On June 27, 2018, the U.S. Food and Drug Administration (FDA) approved the combination of encorafenib and binimetinib for the treatment of patients with unresectable or metastatic melanoma confirmed by FDA-approved testing methods to harbor BRAF V600E or V600K mutations.
This approval was based on a randomized, active-controlled, open-label, multicenter trial (COLUMBUS; NCT01909453) that enrolled 577 patients with unresectable or metastatic melanoma harboring BRAF V600E or V600K mutations. Patients were randomized 1:1:1 to receive treatment. Treatment continued until disease progression or unacceptable toxicity.
About Binimetinib (Mektovi):
Binimetinib is a targeted drug developed based on the MEK pathway. It is a MEK signaling pathway inhibitor developed by Pierre Fabre in France. Binimetinib, with its unique mechanism of action, precisely targets the RAS/RAF/MEK/ERK signaling pathway, bringing new hope to cancer patients carrying BRAF V600E or V600K gene mutations.
Common Adverse Reactions of Mektovi (Bimetinib)
In patients receiving combination therapy with Binimetinib and Encorafenib, common adverse reactions (≥25%) include fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia. 5% of patients receiving combination therapy with Binimetinib and Encorafenib discontinued treatment due to adverse reactions, the most common being bleeding and headache.
About Melanoma
Melanoma is a highly malignant tumor originating from skin pigment cells (melanocytes). It is formed by the malignant transformation of uncontrolled proliferating melanocytes and can originate in the skin (90%), mucous membranes (such as the oral cavity and rectum), or the uvea of the eye. Once it breaches the epidermis and invades the dermis, it has the ability to metastasize to distant sites such as the lungs, liver, brain, and bones via the lymphatic system or bloodstream. Although melanoma accounts for only about 1% of skin cancers, it causes the vast majority of skin cancer-related deaths. It is characterized by rapid progression, early metastasis, and low sensitivity to traditional radiotherapy and chemotherapy, making it the most aggressive type of skin tumor.
It is worth noting that the U.S. Food and Drug Administration (FDA) has also approved the THxIDBRAF test kit (developed by bioMérieux) as a companion diagnostic for the combination therapy of binimetinib and encorafenib.
