| Summary: | Colorectal cancer (CRC) is the second-leading cause of cancer-related deaths globally. <i>BRAF</i> mutation is present in about 10% of CRC patients and is associated with a poor response to chemotherapy. These patients have a relatively poor prognosis. This review aims to assess the efficacy and safety of <i>BRAF</i> inhibitors in <i>BRAF</i>-<i>mutated</i> CRC patients. A literature search was performed on PubMed and Embase, and clinical trials relevant to <i>BRAF</i> inhibitors in CRC were included. Data were extracted for efficacy and safety variables. Two randomized clinical trials (<i>n</i> = 765) and eight non-randomized trials (<i>n</i> = 281) were included based on inclusion criteria. In RCTs, an overall response was reported in 23% of the patients treated with <i>BRAF</i> inhibitor-based regimens compared to 2.5% with control regimens. The hazard ratio of overall survival was also significantly better with triplet encorafenib therapy at 0.52 (95% CI = 0.39–0.70). In single-arm trials, ORR was 17% and 34% in two-drug and three-drug regimens, respectively. <i>BRAF</i> inhibitor-based regimens were safe and effective in the treatment of <i>BRAF</i>-mutated CRC. Large-scale randomized trials are needed to find a suitable population for each regimen. PROSPERO registration No. CRD42023471627.
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