PBAC's latest decision on Entrectinib: Recommended with restriction (2020). Considered for Treatment of locally advanced (Stage IIIB) or metastatic (Stage IV) c-ros proto-oncogene 1 (ROS1)-positive non-squamous or not otherwise specified (NOS) non-small cell lung cancer (NSCLC).
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2020
Submissions
1
2020 → 2020
Eligible population
Patients with ROS1-positive, locally advanced (Stage IIIB) or metastatic (Stage IV) non-squamous or NOS NSCLC, with WHO performance status of 2 or less, who have not received prior ROS1 receptor tyrosine kinase inhibitor treatment or who have developed intolerance to such treatment.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
Single-arm
Primary endpoint
ORR
Pivotal trial size
53 patients
Key trials
ALKA, STARTRK-1, STARTRK-2, PROFILE 1001, Wu 2018, EUCROSS, METROS
Comparator
crizotinib
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis conducted; no ICER calculated by design.