Overview
Encorafenib, also known as BRAFTOVI, is a kinase inhibitor. Encorafenib inhibits BRAF gene, which encodes for B-raf protein, which is a proto-oncogene involved in various genetic mutations. This protein plays a role in regulating the MAP kinase/ERK signaling pathway, which impacts cell division, differentiation, and secretion. Mutations in this gene, most frequently the V600E mutation, are the most commonly identified cancer-causing mutations in melanoma, and have been isolated in various other cancers as well, including non-Hodgkin lymphoma, colorectal cancer, thyroid carcinoma, non-small cell lung carcinoma, hairy cell leukemia and adenocarcinoma of the lung. On June 27, 2018, the Food and Drug Administration approved encorafenib and binimetinib (BRAFTOVI and MEKTOVI, Array BioPharma Inc.) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
Background
Encorafenib, also known as BRAFTOVI, is a kinase inhibitor. Encorafenib inhibits BRAF gene, which encodes for B-raf protein, which is a proto-oncogene involved in various genetic mutations. This protein plays a role in regulating the MAP kinase/ERK signaling pathway, which impacts cell division, differentiation, and secretion. Mutations in this gene, most frequently the V600E mutation, are the most commonly identified cancer-causing mutations in melanoma, and have been isolated in various other cancers as well, including non-Hodgkin lymphoma, colorectal cancer, thyroid carcinoma, non-small cell lung carcinoma, hairy cell leukemia and adenocarcinoma of the lung. On June 27, 2018, the Food and Drug Administration approved encorafenib and binimetinib (BRAFTOVI and MEKTOVI, Array BioPharma Inc.) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
Indication
Encorafenib is indicated in combination with binimetinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation and metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. It is also indicated in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation.
Associated Conditions
- Metastatic Colorectal Cancer (CRC)
- Metastatic Melanoma
- Metastatic Non-Small Cell Lung Cancer
- Unresectable Melanoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/15 | N/A | Not yet recruiting | Vitaccess Ltd | ||
2025/03/20 | Phase 2 | Recruiting | Grupo Español Multidisciplinar de Melanoma | ||
2024/10/15 | Phase 2 | Recruiting | |||
2024/08/29 | Phase 2 | Recruiting | |||
2024/05/13 | Phase 2 | Recruiting | Vall d'Hebron Institute of Oncology | ||
2024/01/08 | Phase 1 | Recruiting | |||
2023/10/26 | Phase 1 | Recruiting | |||
2023/08/14 | Phase 1 | Recruiting | |||
2023/07/03 | Phase 2 | Active, not recruiting | |||
2023/03/14 | Phase 2 | Recruiting | Leiden University Medical Center |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Array BioPharma Inc. | 70255-025 | ORAL | 75 mg in 1 1 | 7/28/2023 | |
| Array BioPharma Inc. | 70255-050 | ORAL | 50 mg in 1 1 | 7/28/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/19/2018 | ||
Authorised | 9/19/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| BRAFTOVI HARD CAPSULE 50MG | SIN16825P | CAPSULE | 50mg | 7/19/2023 | |
| BRAFTOVI HARD CAPSULE 75MG | SIN16824P | CAPSULE | 75mg | 7/19/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| BRAFTOVI encorafenib 75 mg capsule blister pack | 295441 | Medicine | A | 1/3/2019 | |
| BRAFTOVI encorafenib 50 mg capsule blister pack | 295764 | Medicine | A | 1/3/2019 |