ARTG Entry
WELIREG
ARTG entry for WELIREG (belzutifan), ARTG 355338 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Merck Sharp & Dohme
- Active ingredient: belzutifan
- Therapeutic area: Oncology
What it is
WELIREG contains 40 mg of belzutifan per tablet. Belzutifan is an HIF-2α inhibitor used to treat certain cancers and tumours associated with von Hippel-Lindau disease.
Approved indications
— Treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) haemangioblastomas, or pancreatic neuroendocrine tumours (pNET), not requiring immediate surgery. — Treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed cell death 1/ligand 1 (PD-1/L1) and a vascular endothelial growth factor (VEGF)-targeted therapy.
Dosing overview
The recommended dose of WELIREG is 120 mg (three 40 mg tablets) administered orally once daily, with or without food. Treatment should continue until disease progression or unacceptable toxicity occurs.
PBS listing
WELIREG 40 mg tablets are listed on the PBS with one item, authority required restriction, at an ex-manufacturer price of A$22,060.00.
Regulatory history
WELIREG belzutifan 40 mg tablets were first listed on the ARTG on 22 December 2022. The TGA approved WELIREG on 20 December 2022 for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system haemangioblastomas, or pancreatic neuroendocrine tumours, not requiring immediate surgery. In July 2024, the PBAC recommended WELIREG for von Hippel-Lindau disease associated with renal cell carcinoma, central nervous system haemangioblastomas, or pancreatic neuroendocrine tumours not requiring immediate surgery.