Encorafenib (Braftovi)

Targeted Therapy · Approved since 2020

US FDA Approved EU EMA Approved ES Hospital use approved in CRC Oral 26 Clinical Trials
BRAF V600E

Description

Encorafenib is an oral BRAF kinase inhibitor specifically approved for the treatment of metastatic colorectal cancer harboring BRAF V600E mutations. This targeted therapy is administered in combination with cetuximab (an EGFR inhibitor) for patients with BRAF V600E-mutated metastatic colorectal cancer who have received prior therapy. Encorafenib represents a precision medicine approach for this specific molecular subtype of colorectal cancer, which accounts for approximately 8-12% of metastatic colorectal cancers and historically has had poor outcomes with standard chemotherapy.

Mechanism of Action

Encorafenib selectively inhibits BRAF V600E mutant kinase, which is constitutively active in tumors harboring this mutation and drives oncogenic MAPK pathway signaling. By blocking mutant BRAF kinase activity, encorafenib disrupts the aberrant cell proliferation and survival signals that promote tumor growth. The combination with cetuximab provides dual pathway inhibition by simultaneously blocking EGFR-mediated feedback activation that can lead to resistance.

Molecular Targets

Side Effects

Fatigue Nausea Diarrhea Abdominal pain Arthralgia Decreased appetite Vomiting Constipation

Not all side effects are listed. Side effects vary by individual. Always consult your oncologist.

Clinical Trials

NCT06640166 Phase 2
Recruiting
Encorafenib + Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafenib + Cetuximab.
Italy
NCT06411600 Phase 2
Recruiting
Combination Therapy for BRAF-V600E Metastatic CRCm
Spain
NCT05985954 Phase 1
Recruiting
Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With Cetuximab and Encorafenib in Patients With Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy
United States
NCT05725200 Phase 2
Recruiting
Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer
Norway
NCT04673955 Not Applicable
Recruiting
BRAF Inhibitor Encorafenib And Cetuximab Real Life Investigation of Next Generation CRC Treatment
Austria, Germany
NCT07318389 Early Phase 1
Not yet recruiting
ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer
United States
View all 26 clinical trials →