MedPath

Encorafenib

Generic Name
Encorafenib
Brand Names
Braftovi
Drug Type
Small Molecule
Chemical Formula
C22H27ClFN7O4S
CAS Number
1269440-17-6
Unique Ingredient Identifier
8L7891MRB6

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

FDA Approved Products

BRAFTOVI
Manufacturer:Array BioPharma Inc.
Route:ORAL
Strength:50 mg in 1 1
Approved: 2023/07/28
NDC:70255-050
BRAFTOVI
Manufacturer:Array BioPharma Inc.
Route:ORAL
Strength:75 mg in 1 1
Approved: 2023/07/28
NDC:70255-025

Singapore Approved Products

BRAFTOVI HARD CAPSULE 50MG
Manufacturer:Catalent Pharma Solutions LLC, ALMAC Pharma Services Limited (Primary and Secondary Packager), Pierre Fabre Médicament Production (PFMP) (Primary and Secondary Packager)
Form:CAPSULE
Strength:50mg
Online:Yes
Approved: 2023/07/19
Approval:SIN16825P
BRAFTOVI HARD CAPSULE 75MG
Manufacturer:Catalent Pharma Solutions LLC, ALMAC Pharma Services Limited (Primary and Secondary Packager), Pierre Fabre Médicament Production (PFMP) (Primary and Secondary Packager)
Form:CAPSULE
Strength:75mg
Online:Yes
Approved: 2023/07/19
Approval:SIN16824P

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