Cabozantinib [CABO3]
The treatment of treatment-naïve to vascular endothelial growth factor (VEGF)- targeted therapy and with intermediate poor risk advanced renal cell carcinomawhere the following criteria are met:
- This application is being made by and the first cycle of systemic anti-cancer therapy with cabozantinib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
- This patient has a histologically- or cytologically-proven diagnosis of renal cell carcinoma (RCC) which either has a clear cell component or is one of the types of RCC as indicated below. Please indicate below which RCC histology applies to this patient:
- RCC with a clear cell component or
- papillary RCC or
- chromophobe RCC or
- collecting duct RCC (Bellini collecting duct RCC) or
- medullary RCC or
- mucinous tubular and spindle cell RCC or
- multilocular cystic RCC or
- XP11 translocation RCC or
- unclassified RCC
- The patient has either metastatic disease or inoperable locally advanced disease
- Cabozantinib is either being used as 1st line treatment for renal carcinoma or as 2nd line treatment in patients previously treated with 1st line nivolumab plus ipilimumab. Please mark below in which setting cabozantinib is being used in this patient:
- 1st line treatment or
- 2nd line treatment after 1st line therapy with nivolumab plus ipilimumab Note: NHS England does not fund cabozantinib in this indication after disease progression with pembrolizumab plus lenvatinib or avelumab plus axitinib or nivolumab plus cabozantinib.
- The patient has not previously received any vascular endothelial growth factor (VEGF)-targeted systemic therapy unless the patient commenced 1st line treatment with whichever of pazopanib or sunitinib or tivozanib as the immediate prior therapy and this had to be stopped within 3 months of its start and solely because of dose-limiting toxicity and in the clear absence of disease progression. Please mark which of these 2 scenarios below applies to this patient:
- the patient has not previously received any vascular endothelial growth factor (VEGF)-targeted systemic therapy or
- has only previously received treatment with 1st line pazopanib or sunitinib or tivozanib as the immediate prior therapy and which had to be stopped within 3 months of its start solely because of dose-limiting toxicity and in the clear absence of disease progression
- The patient has intermediate risk OR poor risk advanced renal cell carcinoma as defined by the International Metastatic Renal Cell Carcinoma Database Consortium. Good risk patients are not eligible for cabozantinib therapy. or Intermediate risk is defined as having 1 or 2 risk factors and poor risk as having >=3 factors, these factors being:
- Time from diagnosis of RCC to need for systemic therapy of <1 year
- Haemoglobin < lower limit of normal
- Corrected calcium > upper limit of normal
- Karnofsky performance status <80%
- Neutrophils > upper limit of normal
- Platelet count > upper limit of normal Please indicate whether patients has intermediate risk or poor risk disease:
- intermediate risk poor risk
- poor risk
- The patient has an ECOG performance status of either 0 or 1 or 2
- If the patient has brain metastases, then these have been treated and are stable.
- Cabozantinib is to be continued until loss of clinical benefit or unacceptable toxicity or patient choice to stop treatment or cabozantinib can be stopped with a planned treatment break following the protocol used in the STAR trial. Note: following 24 weeks of continuous cabozantinib therapy, and if there is no evidence of disease progression on therapy, patients and clinicians may choose to stop treatment for a planned drug free interval/treatment break and then restart cabozantinib on disease progression as per the STAR trial design. Note: all patients who undergo planned treatment breaks must have regular clinical and radiological assessments and then have the option of restarting cabozantinib on disease progression. Note: if the patient benefits from restarting after the first planned treatment break, they can take further planned treatments breaks following the same strategy, i.e. after a further 24 weeks on treatment. Ref for the STAR trial: Brown JE, Royle KA, Gregory W, Ralph C, Maraveyas A, Din O et al. ‘Temporary treatment cessation versus continuation of first-line tyrosine kinase inhibitor in patients with advanced clear cell renal cell carcinoma (STAR): an open-label, non-inferiority, randomised, controlled, phase 2/3 trial.’ The Lancet Oncology,2023, February 13 https://doi.org/10.1016/S1470-2045(22)00793-8.
- A formal medical review as to whether treatment with cabozantinib should continue or not will be scheduled to occur at least by the end of the first 8 weeks of treatment
- When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, a treatment break approval form will be completed to restart treatment with cabozantinib, unless the patient is following a planned intermittent treatment schedule as evidenced by the STAR trial and described above.
- Cabozantinib is to be otherwise used as set out in its Summary of Product Characteristics
NHS funded From: 01 January 2019
Additional information
Current Form Version
Note
The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.
If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.