FDA Oncology Announcements

BRAF inhibitor × Gastrointestinal × Clear all

4 Announcements

FDA grants traditional approval to encorafenib for metastatic colorectal cancer with a BRAF V600E mutation

Drugs: Braftovi (encorafenib) · BRAF inhibitor, cetuximab · Anti-EGFR antibody
Condition: Gastrointestinal

FDA grants accelerated approval to encorafenib with cetuximab and mFOLFOX6 for metastatic colorectal cancer with a BRAF V600E mutation

Drugs: Braftovi (encorafenib) · BRAF inhibitor, cetuximab · Anti-EGFR antibody
Condition: Gastrointestinal

FDA grants accelerated approval to dabrafenib in combination with trametinib for unresectable or metastatic solid tumors with BRAF V600E mutation

Drugs: Tafinlar (dabrafenib) · BRAF inhibitor, Mekinist (trametinib) · MEK inhibitor
Condition: Other solid neoplasm

FDA approves encorafenib in combination with cetuximab for metastatic colorectal cancer with a BRAF V600E mutation

Trial: BEACON CRC
Drugs: BRAFTOVI (encorafenib) · BRAF inhibitor, cetuximab · Anti-EGFR antibody
Condition: Gastrointestinal