Tivozanib [TIV1]

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

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with tivozanib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. 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 3.The patient has either metastatic disease or inoperable locally advanced disease
  1. Tivozanib 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 tivozanib 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 tivozanib after disease progression with pembrolizumab plus lenvatinib or avelumab plus axitinib or nivolumab plus cabozantinib. 5.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 cabozantinib as the immediate prior therapy and this had to be stopped within 3 months of its start 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
  • the patient has only previously received treatment with 1st line pazopanib or sunitinib or cabozantinib 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
  1. If the patient has brain metastases, then these have been treated and are stable
  2. The patient has an ECOG performance status of either 0 or 1. A patient with a performance status of 2 is not eligible for tivozanib
  3. Tivozanib is to be continued until loss of clinical benefit or unacceptable toxicity or patient choice to stop treatment or tivozanib can be stopped with a planned treatment break following the protocol used in the STAR trial. Note: following 24 weeks of continuous tivozanib 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 tivozanib 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 tivozanib 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.
  4. A formal medical review as to whether treatment with tivozanib should continue or not will be scheduled to occur at least by the end of the first 8 weeks of treatment.
  5. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle 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.
  6. Tivozanib is to be otherwise used as set out in its Summary of Product Characteristics

[NHS funded]{.badge .rounded-pill .bg-success} From: 19 June 2018

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NICE Technology Appraisal: TA512 (21 March 2018)

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