Cabometyx® (Cabozantinib) now available for eligible patients with non-clear cell renal cell carcinoma via the PBS

• Cabometyx® is now available on the Pharmaceutical Benefits Scheme (PBS) for the treatment of Stage IV non-clear cell renal cell carcinoma (nccRCC).^1,2
• Previously patients with Stage IV nccRCC had no PBS-reimbursed treatment option.²
• NccRCC is a diverse group of tumours with distinct unique features, and accounts for approximately 20% of all renal cell carcinoma (RCC).³

 

SEPTEMBER 1 2024: Cabometyx® (Cabozantinib), a once-daily oral medication, is now available on the Pharmaceutical Benefits Scheme (PBS) for eligible patients with Stage IV non-clear cell renal cell carcinoma. Previously, patients living with Stage IV non-clear cell renal cell carcinoma had no PBS-reimbursed treatment option.²

 

Cabometyx® is a tyrosine kinase inhibitor (TKI) that is PBS-reimbursed as monotherapy for Stage IV renal cell carcinoma (RCC) – now for both clear cell (ccRCC) and non-clear cell (nccRCC) subtypes – in treatment-naïve adults with intermediate or poor risk, and in adults following prior treatment with TKI therapy.^1,2

 

RCC is the seventh-most common malignancy globally.⁴ Each year, around 4,500 Australians are diagnosed with kidney cancer and roughly 90% of these are RCC.⁴ Within RCC, non-clear cell RCC accounts for approximately 20% of all RCC, whereas clear cell RCC constitutes approximately 80%.³

 

Until now, the PBS reimbursement of Cabometyx in Australia has been available to patients with Stage IV RCC but restricted to only those with clear cell subtypes. Unlike clear cell RCC, non-clear cell RCC includes a diverse group of tumours with distinct histological and molecular features.³ For this reason, clinical trials for RCC treatments have predominantly focused on clear cell RCC cases since it is the more common and uniform RCC population.³

 

Given this history and the rarity of the condition, patients with Stage IV non-clear cell RCC have been excluded from funded access to treatment. Thus, treatment options for non-clear cell RCC have been limited to clinical trials, compassionate access schemes or self-funding.

 

This expanded PBS-funded access to Cabometyx means that Australian patients living with non-clear cell RCC may now be eligible for equitable, timely and sustainable access to a treatment option.

 

Dr Lewis Au, Medical Oncologist and Postdoctoral Research Fellow, at the Peter MacCallum Cancer Centre, sees the expanded access to Cabometyx as an important development in creating equitable treatment for all Australians affected by RCC. 

 

“We are delighted that patients affected by non-clear cell renal cell carcinoma now have access to an effective treatment via the Pharmaceutical Benefits Scheme, where previously there were no funded options. This represents a significant step forward in improving health outcomes for everyone affected by these rare cancers, ensuring that more patients can receive the care they need and deserve.”  

 

Courtney Dodds, who is living with non-clear cell RCC, says the listing will be a relief to people living with rare cancer.

 

“Living with a rare disease is extremely difficult for a number of reasons, but access to treatment is one of the biggest hurdles we face regularly. In some cases, there are no available treatments and even when they do exist, they can be very costly. The news that this treatment will now be made available via the PBS is very welcome and will be a relief to many people living with non-clear cell renal cell carcinoma.”

 

Ms Christine Cockburn, CEO of Rare Cancers Australia, also welcomed the announcement saying it was a positive step towards equitable access for approximately 800 people living with Stage IV non-clear cell RCC in Australia.

 

“The listing of Cabometyx on the PBS is encouraging for our rare cancer community, who too often don’t receive the required level of support, or access to the same treatment options, as those with more common cancers.,” said Ms Cockburn.

 

Simon Higgins, Director of Market Access & Public Affairs at Ipsen in Australia and New Zealand, says this listing is an important milestone for Australians impacted by non-clear cell RCC, who were previously not able to access reimbursed treatment.

 

“Ipsen is committed to addressing the challenges facing Australians impacted by rare and less common cancers and conditions. We acknowledge the efforts of all stakeholders that have contributed to this outcome within the current constraints of our health system.” Said Higgins.

 

ENDS

 

 

About Cabometyx

Cabometyx (Cabozantinib) is a medication that blocks multiple receptors known as tyrosine kinases. These receptors are involved in tumour growth and progression of cancers to other sites in the body, known as metastases. By blocking these receptors, Cabometyx can help stop the growth of tumours and/or metastases or even lead to a reduction in tumour size.¹

 

Cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (RCC) in treatment-naïve adults with intermediate or poor risk, and in adults following prior treatment with vascular endothelial growth factor targeted therapy.¹

 

Contraindications: Hypersensitivity to the active substance or to any of the excipients.¹

Most frequent adverse events of any grade (≥25% of patients) in RCC population: Diarrhoea, fatigue, nausea, decreased appetite, Palmar-plantar erythrodysaesthesia syndrome, hypertension, weight decreased, vomiting, dysgeusia, constipation and AST increased. Hypertension was observed more frequently in the treatment-naïve RCC population (67%) compared to RCC patients following prior VEGF-targeted therapy (37%).¹

 

Please see Consumer Medicines Information for further information, including on special warnings and precautions, adverse effects and drug interactions.

 

▼ 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.

 

About Ipsen

Ipsen is a global biopharmaceutical company, improving patients’ lives through research and innovation in oncology, rare disease & neuroscience.

 

References

1. Cabometyx Product Information
2. Pharmaceutical Benefits Scheme, Medicine Status, CABOZANTINIB. Available at: https://www.pbs.gov.au/medicinestatus/document/341.html. Accessed August 2024.
3. John A et al. Navigating the Current Landscape of Non-Clear Cell Renal Cell Carcinoma: A Review of the Literature. Curr Oncol 2023;30:923-37. Available at:  https://doi.org/10.3390/curroncol30010070. Accessed August 2024.
4. Cancer Council (2022). Understanding Kidney Cancer. Available at: https://www.cancercouncil.com.au/wp-content/uploads/2022/11/Understanding-Kidney-Cancer-2022.pdf. Accessed August 2024.

 

Contact details:

For further information or to request an interview, please contact:

Sarah Rumsey, Account Director at Palin Communications

sarah@palin.com.au, +61 488 060 047