CABOMETYX

What it is

CABOMETYX is a film-coated tablet containing cabozantinib (S)-malate equivalent to 20 mg, 40 mg or 60 mg of cabozantinib.

Approved indications

— Advanced renal cell carcinoma in treatment-naïve adults with intermediate or poor risk. — Advanced renal cell carcinoma in adults following prior treatment with vascular endothelial growth factor targeted therapy. — First-line advanced renal cell carcinoma in combination with nivolumab. — Hepatocellular carcinoma in adults who have previously been treated with sorafenib. — Locally advanced or metastatic differentiated thyroid carcinoma in adult and paediatric patients aged 12 years and older that has progressed during or after prior VEGFR-targeted therapy and is radioactive iodine refractory or ineligible. — Locally advanced, unresectable or metastatic, well-differentiated extra-pancreatic or pancreatic neuroendocrine tumours in adult patients who have progressed on at least one prior systemic therapy other than a somatostatin analogue.

Dosing overview

Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs. When dose reduction is necessary in monotherapy, it is recommended to reduce to 40 mg daily, and then to 20 mg daily.

Key safety warnings

Dose interruptions are recommended for management of CTCAE grade 3 or greater toxicities or intolerable grade 2 toxicities. Dose reductions are recommended for events that, if persistent, could become serious or intolerable.

Regulatory history

CABOMETYX was first listed on the ARTG on 19 January 2018, with three registered strengths: 20 mg, 40 mg and 60 mg film-coated tablets. In December 2017, the PBAC recommended listing for treatment of Stage IV clear cell variant renal cell carcinoma on a cost-minimisation basis against nivolumab, with considered non-inferior efficacy to nivolumab and manageable increased toxicity. In November 2020, the PBAC recommended a change to extend the RCC indication to include patients not previously treated with a tyrosine kinase inhibitor. In November 2023, the PBAC did not recommend listing for differentiated thyroid cancer due to an uncertain economic model with likely underestimated cost-effectiveness ratio, with a nomination for Early Re-entry resubmission pathway. In March 2024, the PBAC recommended CABOMETYX in combination with nivolumab for renal cell carcinoma, recommended an amendment to the existing RCC listing for non-clear cell variants, and recommended listing for differentiated thyroid cancer. In July 2025, the PBAC recommended listing for unresectable or metastatic, well-differentiated extra-pancreatic or pancreatic neuroendocrine tumours in patients who have progressed on at least one prior systemic therapy other than a somatostatin analogue.