Product Dossier
ALUNBRIG
Product Dossier for ALUNBRIG (brigatinib, Takeda Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Takeda Pharmaceuticals
- Active ingredient: brigatinib
- Therapeutic area: Oncology
- Same area: TALZENNA
- Same area: ZARZIO
What it is
ALUNBRIG is brigatinib, available as film-coated tablets in strengths of 30 mg, 90 mg, and 180 mg.
Approved indications
— ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients.
Dosing overview
The recommended starting dose of ALUNBRIG is 90 mg once daily for the first 7 days, then 180 mg once daily. Treatment should continue as long as clinical benefit is observed. Dosing interruption and/or dose reduction may be required based on individual safety and tolerability.
Key safety warnings
ALK-positive NSCLC status should be known prior to initiation of ALUNBRIG therapy, and a validated ALK assay is necessary for the selection of ALK-positive NSCLC patients. If a dose of ALUNBRIG is missed, or vomiting occurs after taking a dose, an additional dose should not be administered and the next dose of ALUNBRIG should be taken at the scheduled time.
PBS listing
ALUNBRIG tablets are listed on the PBS in 30 mg, 90 mg, and 180 mg strengths, with authority required restrictions. Ex-manufacturer prices are A$1580.11 for the 30 mg tablet and A$6320.43 for both the 90 mg and 180 mg tablets.
Regulatory history
ALUNBRIG received ARTG registration on 6 March 2019, with seven registered variants covering 30 mg, 90 mg, and 180 mg film-coated tablets in blister pack and bottle presentations. The PBAC recommended ALUNBRIG listing in November 2019 as an authority required monotherapy for locally advanced or metastatic ALK-positive NSCLC, cost-minimised against alectinib.