Ipsen Australia welcomes the Pharmaceutical Benefits Scheme (PBS) listing of Cabometyx® (cabozantinib) for the treatment of patients with unresectable or metastatic, well-differentiated extra-pancreatic neuroendocrine tumour (epNET) or pancreatic neuroendocrine tumour (pNET) who have progressed on at least one prior systemic therapy other than a somatostatin analogue (SSA).1
Neuroendocrine tumours (NETs) are a rare and complex disease that affects neuroendocrine cells throughout the body.3 Often found in vital organs, including the lungs, pancreas, gastrointestinal tract, and liver, NETs can present with non-specific symptoms, making diagnosis challenging in the early stages.3 The first global survey of patients with NETs revealed 29% required ≥ 5 years for a NET diagnosis, and 58% of patients had metastases at the time of diagnosis.4
Cabozantinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumour growth and angiogenesis, pathological bone remodelling, drug resistance, and metastatic progression of cancer.5
This PBS listing was based on the Phase III trial of Cabozantinib to treat advanced neuroendocrine tumours. The trial enrolled two independent cohorts of patients, those with epNETs and those with pNETs who had received prior peptide receptor radionuclide therapy or targeted therapy, or both.6 The primary end point of progression-free survival (PFS), assessed by blinded independent central review, demonstrated statistically significant results for both cohorts treated with cabozantinib compared to the control arm (placebo).6
In the cohort of 203 patients with epNETs, the median PFS with cabozantinib was 8.4 months, as compared with 3.9 months with placebo (hazard ratio [HR] 0.38; 95% confidence interval [CI], 0.25 to 0.59; P<0.001).6 In the cohort of 95 patients with pNETs, the median PFS with cabozantinib was 13.8 months, as compared with 4.4 months with placebo (HR, 0.23; 95% CI, 0.12 to 0.42; P<0.001).6 Grade 3 or higher adverse events were noted in 62 to 65% of the patients treated with cabozantinib, as compared with 23 to 27% of the patients who received placebo.6 Common treatment-related adverse events of grade 3 or higher included hypertension, fatigue, diarrhea, and thromboembolic events.6
According to Dr Lewis Au, a Medical Oncologist at the Peter MacCallum Cancer Centre, Australians living with epNET or pNET face many challenges, including accessing effective treatment options in their specific circumstances.
“This is very welcomed and important news. For the many Australians living with this less common cancer, this PBS listing will provide access to another treatment option, which is much needed,” said Dr Au.
Meredith Cummins, Chief Executive Officer of NeuroEndocrine Cancer Australia, commented that the non-specific symptoms of pNET and epNET often mean patients present with progressed disease, as patients may seek a diagnosis from multiple specialists and go through a variety of tests before an accurate diagnosis is achieved.
“As a result of this complicated and drawn-out process, almost a third of people globally may be living without a diagnosis for at least five years. During this time, the disease may have progressed, andthe quality of life can significantly decline. Government-funded access to a new treatment option for patients with unresectable or metastatic NETs that aren’t controlled with other systemic treatment is most welcome,” said Ms Cummins.
Christina Xinos, Medical Director at Ipsen Australia, says Ipsen is proud to bring this innovation to the Australian market.
“The PBS listing of Cabometyx is welcome news for those impacted by this rare cancer. Ipsen’s focus on improving health outcomes in rare conditions like NET drives us every day to make options accessible to patients and healthcare professionals.”
PBS Information: Refer to PBthe S schedule for full Authority information
To view the Product Information before prescribing, visit https://rss.medsinfo.com.au/is/pi.cfm?product=ispcabot or call Ipsen Medical Information on 1800 317 033
CABOMETYX® is a registered trademark. To request medical information on Ipsen’s products, report an adverse event,t or report a complaint, please email [email protected] or call Ipsen Medical Information on 1800 317 033.
Ipsen Pty Ltd. ABN 47 095 036 909. Level 5, 627 Chapel Street, South Yarra VIC 3141 Australia. W: www.ipsen.com/aus
Date of preparation: January 2026. CMX-AU-000297
About Ipsen
Ipsen is a global biopharmaceutical company, improving patients’ lives through research and innovation in oncology, rare disease & neuroscience.
About Cabometyx
Cabometyx contains cabozantinib, a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumour growth and angiogenesis, pathologic bone remodelling, drug resistance, and metastatic progression of cancer. Cabozantinib was evaluated for its inhibitory activity against a variety of kinases and was identified as an inhibitor of MET (hepatocyte growth factor receptor protein) and VEGF (vascular endothelial growth factor) receptors. In addition, cabozantinib inhibits other tyrosine kinases, es including the GAS6 receptor (AXL), RET, ROS1, TYRO3, MER, the stem cell factor receptor (KIT), TRKB, Fms-like tyrosine kinase-3 (FLT3), and TIE-2. 5
In Australia, Cabometyx is currently indicated as:5
- Monotherapy for advanced renal cell carcinoma (aRCC).
- in treatment-naïve adults with intermediate or poor risk
- in adults following prior treatment with vascular endothelial growth factor targeted therapy in combination with nivolumab for the first-line treatment of aRCC in adults.
- Monotherapy for the treatment of adults and paediatric patients aged 12 years and older living with locally advanced or metastatic differentiated thyroid carcinoma, refractory or not eligible to radioactive iodine, who have progressed during or after prior VEGFR-targeted therapy.
- Monotherapy for the treatment of hepatocellular carcinoma in adults who have previously been treated with sorafenib.
- Monotherapy for adult patients with local advanced/unresectable or metastatic, well-differentiated pancreatic (pNET) and extra-pancreatic (epNET) neuroendocrine tumors who have progressed following at least one prior systemic therapy other than somatostatin analogues.
▼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.
Reference
- Pharmaceutical Benefits Scheme. Access online here.
- NeuroEndocrine Cancer Australia. Accessed on 11 November 2025 here.
- NeuroEndocrine Cancer Australia. Accessed on 11 November 2025 here.
- Singh S et al. Patient-Reported Burden of a Neuroendocrine Tumor (NET) Diagnosis: Results from the First Global Survey of Patients with NETs. J Glob Oncol. 2016 Jun 8;3(1):43-53.
- Cabometyx approved Product Information. Access online here.
- Chan JA et al. Phase 3 Trial of Cabozantinib to Treat Advanced Neuroendocrine Tumors. N Engl J Med. 2025 Feb 13;392(7):653-665
Source: Sponsored by Ipsen.
