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NICE draft guidance rejects first-line use of Cabometyx

The National Institute for Health and Care Excellence (NICE) has issued draft guidance rejecting first-line use of Ipsen/Exelixis’ Cabometyx in renal cancer on the NHS.


Cabometyx (cabozantinib) is a treatment for adult patients with advanced renal cell carcinoma (RCC) following prior vascular endothelial growth factor (VEGF)-targeted therapy.


This month, [June] NICE said Cabozantinib was not recommended, within its marketing authorisation, for adults with untreated advanced renal cell carcinoma that is intermediate or poor risk.


Clinical trial evidence shows that cabozantinib extends the period of time until cancer progresses compared with current treatment. But NICE said the evidence on whether cabozantinib increases the overall length of time people live is “less certain”.

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Current treatment for untreated advanced renal cell carcinoma is usually pazopanib or sunitinib.


In its appraisal consultation document, NICE said the main evidence on the clinical effectiveness of cabozantinib came from CABOSUN. This phase 2 clinical trial compared cabozantinib with sunitinib in 157 patients with untreated intermediate or poor risk advanced renal cell carcinoma. The primary outcome of the trial was progression-free survival. Overall, survival was a secondary outcome, NICE said.


“The company explained that CABOSUN was not designed to be a registration trial, but was submitted to the regulators because the results were thought to be encouraging. The committee concluded that the small number of patients in the trial makes the results uncertain,” NICE stated.


“It is at least as effective as current treatment but it is not clear how much further benefit it offers. Cabozantinib does not meet NICE’s end-of-life criteria. The cost effectiveness estimates are higher than what NICE normally considers acceptable,” NICE said.

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