Cabozantinib [CABO2]

The treatment of previously treated advanced renal cell carcinoma where the following criteria are met:

  1. 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
  2. The 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
  1. The patient has either metastatic disease or inoperable locally advanced disease
  2. The patient has previously received at least 1 vascular endothelial growth factor (VEGF)-targeted systemic therapy and has not been previously treated with cabozantinib. Note: the patient may also have received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody for renal cancer.
  3. The patient has progressed on previous treatment or within 6 months of most recent dose of VEGF inhibitor
  4. The patient has a performance status of 0 or 1
  5. If the patient has brain metastases then these have been treated and are stable
  6. 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.
  7. 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
  8. 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 unless the patient is following a planned intermittent treatment schedule as evidenced by the STAR trial and described above.
  9. Cabozantinib will otherwise be used as set out in its Summary of Product Characteristics (SPC).

[NHS funded]{.badge .rounded-pill .bg-success} From: 08 November 2017

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CDF Managed Access: NA

NICE Technology Appraisal: TA463 (08 November 2017)

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