PBAC's latest decision on Encorafenib: Recommended with restriction (2025). Considered for Advanced or metastatic non-small cell lung cancer (Stage IV NSCLC) with a BRAF V600E mutation who have not received prior systemic treatment in the metastatic setting.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
—
ICER not stated
Submissions
2
first 2021
Submissions
2
2021 → 2025
Eligible population
Adult patients with advanced or metastatic (Stage IV) NSCLC with a BRAF V600E mutation who have not received prior systemic treatment in the metastatic setting, with WHO performance status of 0-2.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
Single-arm
Primary endpoint
ORR
Pivotal trial size
59 patients
Key trials
PHAROS, BRF113928, KN-189
Comparator
dabrafenib in combination with trametinib
ICER note
ICER not stated in the publicly available portion of this document.
Submission history
Mar 2021: Recommended with restriction · Authority Required
Nov 2025: Recommended with restriction · Authority Required