Drug updated on 5/17/2024

Dosage FormCapsule (oral; 75 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies


  • Indicated, in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
  • Indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

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  • Encorafenib (Braftovi) is indicated for the treatment of patients with unresectable or metastatic melanoma and colorectal cancer, both harboring a BRAF V600E or V600K mutation. It is utilized in combination with binimetinib for melanoma and cetuximab for colorectal cancer.
  • Twelve systematic reviews/meta-analyses provided information on Braftovi's efficacy and safety profiles in comparison to other targeted therapies.
  • The medication demonstrates significant efficacy in treating BRAF-mutant metastatic melanoma and colorectal cancer (CRC), resulting in prolonged overall survival rates, progression-free survival rates, and favorable overall response rates.
  • For Colorectal Cancer (CRC), Braftovi improves outcomes when used with anti-EGFR therapies such as cetuximab. This was evident from the BEACON CRC trial where encorafenib plus cetuximab showed superior overall survival compared to conventional therapies like irinotecan/FOLFIRI plus cetuximab.
  • Regarding the safety profile, while generally safe and effective, particular attention needs to be paid to specific side effects such as severe cutaneous adverse reactions (SCARs).
  • In treating Metastatic Melanoma, Braftovi combined with binimetinib has been found superior in terms of overall response rate compared to double combinations like dabrafenib + trametinib. Fewer serious adverse events were noted than with triple combinations involving atezolizumab + vemurafenib + cobimetinib.
  • Population considerations highlight that patients with BRAF V600E-mutant tumors, especially those with CRC, benefit from this therapy, underscoring the importance of genetic profiling during the treatment selection process.
  • Age and prior therapy history, including immunotherapy, have been identified as relevant factors influencing the risk of adverse reactions, thus demonstrating the need for patient-specific considerations during the decision-making process.

Product Monograph / Prescribing Information

Document TitleYearSource
Braftovi (encorafenib) Prescribing Information.2023Array BioPharma Inc., Boulder, CO

Systematic Reviews / Meta-Analyses

Document TitleYearSource
BRAF inhibitors in braf-mutated colorectal cancer: a systematic review.2023Journal of Clinical Medicine
Comparative efficacy and safety of targeted therapies for BRAF-mutant unresectable or metastatic melanoma: results from a systematic literature review and a network meta-analysis.2022Cancer Treatment Reviews
Acceptability of drugs in the treatment of unresectable/metastatic braf v600-mutant melanoma: a systematic review and network meta-analysis.2022Frontiers in Oncology
Systematic review of randomised clinical trials and observational studies for patients with RAS wild-type or BRAFV600E-mutant metastatic and/or unresectable colorectal cancer. 2022Critical Reviews in Hematology/Oncology
Systematic review of BRAF/MEK inhibitors-induced Severe Cutaneous Adverse Reactions (SCARs). 2021Journal of the European academy of Dermatology & Venereology
Comparative efficacy of dabrafenib + trametinib versus treatment options for metastatic melanoma in first-line settings. 2021Journal of Comparative Effectiveness Research
A matching-adjusted indirect comparison of combination nivolumab plus ipilimumab with BRAF plus MEK inhibitors for the treatment of BRAF-mutant advanced melanoma.2021ESMO Open
An appraisal of emerging second line therapies for metastatic colorectal cancer.2020Expert Rreview of Gastroenterology & Hepatology
Network indirect comparison of 3 BRAF + MEK inhibitors for the treatment of advanced BRAF mutated melanoma.2020Clinical and Translational Oncology
A systematic literature review and network meta-analysis of effectiveness and safety outcomes in advanced melanoma. 2019European Journal of Cancer
Efficacy and adverse events in metastatic melanoma patients treated with combination BRAF plus MEK inhibitors versus BRAF inhibitors: a systematic review.2019Cancers
Cardiovascular adverse events associated with BRAF and MEK inhibitors: a systematic review and meta-analysis.2019JAMA Network Open

Clinical Practice Guidelines