Drug updated on 3/28/2024
| Dosage Form | Capsule (oral; 75 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
Summary
- Encorafenib (Braftovi) is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with binimetinib. It is also used in combination with cetuximab for treating adult patients with metastatic colorectal cancer (CRC) having a BRAF V600E mutation.
- A network meta-analysis study found that encorafenib plus binimetinib was superior to dabrafenib plus trametinib and vemurafenib plus cobimetinb regarding overall response rate and had fewer serious adverse events compared to other double and triple combinations therapies.
- Another systematic review suggested that immunotherapy drugs like ipilimumab or nivolumab have better acceptability than most targeted therapies including encorafenif combined therapy, indicating lower risk of adverse events among these patient populations.
- In terms of severe cutaneous adverse reactions (SCARs), it has been observed from case studies that SCARs are rare but can occur within the first fifteen days of treatment accompanied by hepatic and renal involvement when using vemurafeni; switching to dabrafenif after resolution seems safe.
- Seven Systematic Reviews / Meta-Analyses were reviewed which provided insights into efficacy profiles as well as safety considerations associated specifically with encorafenif use in different therapeutic combinations.
- Cardiovascular risks were highlighted in one report where combined therapy involving BRAF inhibitors such as Braftovi showed an increased risk of pulmonary embolism, decrease in left ventricular ejection fraction, arterial hypertension compared to monotherapies; however myocardial infarction rates remained similar across groups suggesting careful cardiovascular monitoring during administration may be necessary especially among younger patients (<55 years).
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Braftovi (encorafenib) Prescribing Information. | 2023 | Array BioPharma Inc., Boulder, CO |