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NICE approves cabozantinib for patients with advanced renal cell carcinoma

The UK affiliate of Ipsen has announced that eligible patients with advanced kidney cancer could now benefit from treatment with Ipsen’s innovative therapy Cabometyx® (cabozantinib) via the NHS in England and Wales, following recommendation for use by NICE in their Final Appraisal Determination (FAD).

Cabozantinib is a once-daily oral tablet which targets multiple pathways involved in tumour growth and is licensed for adults with advanced renal cell carcinoma (RCC), following prior vascular endothelial growth factor (VEGF)-targeted therapy.1 It has been shown to significantly extend overall survival and progression free survival compared with everolimus, with over five times more patients responding to treatment.2 The committee concluded that because of its multi-targeted approach, cabozantinib would likely have additional benefits for some patients and so could be considered innovative.
The announcement comes in the wake of the first annual World Kidney Cancer Day (22 June), which recently shed light on the rising need for new targeted treatments to tackle the increasing rates of kidney cancer incidence, especially as up to 30% of people diagnosed are in the late/advanced stages of the disease.3,4 The approval of cabozantinib strengthens Ipsen’s commitment to improving patient health and quality of life within cancer care and follows the news on 12 June that the Scottish Medicines Consortium approves routine prescribing of cabozantinib across NHS Scotland.
Cabozantinib has demonstrated statistically significant superiority in overall survival, progression-free survival, and objective response rate compared with everolimus in patients with RCC who have failed previous treatment with anti-angiogenic therapy.5 Last year cabozantinib was granted a Promising Innovation in Medicine (PIM) designation by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), while nearly 250 English, Welsh and Northern Irish patients with advanced RCC have received cabozantinib via the Ipsen Managed Access Programme prior to today’s announcement.6
The approval of cabozantinib is welcome news for clinicians and people with advanced kidney cancer in England and Wales,” said Professor Robert Hawkins, Consultant Oncologist at Manchester’s Christie NHS Foundation Trust. “We have been fortunate enough to already see the benefits of this treatment in patients enrolled in the managed access scheme, and we are delighted that wider access means more people with kidney cancer will be able to live longer. There is a real need for new treatments among patients with advanced or relapsing kidney cancer and cabozantinib has demonstrated strong potential among these patients where there is an urgent need for new advances that extend and improve lives.”
Kidney cancer is the seventh most common cancer in the UK with RCC accounting for 75% of all kidney cancers, responsible for around 12,000 new cases every year in the UK, or around 33 per day.7
The positive recommendation by NICE represents a huge milestone for advanced kidney cancer patients in England and Wales” commented Nick Turkentine, CEO of Kidney Cancer UK. “We believe it brings us one step closer to fighting kidney cancer, which is rapidly on the rise in the UK. There is a clear unmet need for treatments to patients with late-stage disease and as such the approval of this effective therapy option offers new hope for patients and their families”.
Ewan McDowall, Vice President of Commercial Operations, Ipsen UK & Ireland commented on today’s announcement by NICE saying, “At a time where the NHS is under increasing pressure we have taken our responsibility one step further by implementing an industry first of its kind: a managed access programme throughout the UK that provides cabozantinib free of charge for patients for the duration of their treatment. To date nearly 300 patients in the UK have benefited from cabozantinib through this Ipsen initiative, whilst the NICE process took place. We are delighted that now any eligible patient in the UK can benefit from cabozantinib. These patients don’t have time to wait.”


  1. Cabozantinib Summary of Product Characteristics
  2. Choueiri TK, Escudier B, Powles T et al. Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): final results from randomised, open-label, phase 3 trial. FLancet Oncol. 2016; 17(7):917-27
  3. Cancer Research UK. Kidney Cancer Incidence Statistics. Available from:… [Last accessed July 2017]
  4. Bracarda S. Metastatic Renal Cell Carcinoma: Pathogenesis and the Current Medical Landscape. European Urology Supplements 8. 2009. 787–792
  5. Choueiri TK, Escudier B, Powles T, et al. Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov;373:1814-1823.
  6. Ipsen Data on File: CMX-UK-000372
  7. KCUK. Incidence of Kidney Cancer. Available from:… [Last accessed: July 2017]