Drug updated on 5/17/2024
| 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.
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Summary
- 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 Title | Year | Source |
|---|---|---|
| Braftovi (encorafenib) Prescribing Information. | 2023 | Array BioPharma Inc., Boulder, CO |