The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended against the use of sunitinib (Sutent) as an adjuvant treatment of adult patients at a high risk of recurrent renal cell carcinoma (RCC) following nephrectomy (surgical removal of the cancerous kidney). However, the CHMP’s recommendation is not binding but will now be taken into consideration by the European Commission (EC).
In the US, sunitinib is approved for the adjuvant treatment of RCC at high risk of recurrence following nephrectomy, but there is currently no approved adjuvant treatment option available in the European Union (EU).
“We remain confident in the potential of Sutent for RCC patients at high risk of their cancer returning after surgery who today are restricted to a wait and see, or more accurately, a wait and worry approach,” said Dr Mace Rothenberg, chief development officer, Oncology, Pfizer Global Product Development. “We will continue to work closely with the European Medicines Agency as they complete their review and render a decision on this application.”
Adjuvant sunitinib for patients at high risk of recurrent RCC following nephrectomy is currently being appraised by the National Institute for Health and Care Excellence (NICE) for use within NHS England and Wales. However, the appraisal has been put on hold until September 2018 for the collection of further evidence to prove the cost-effectiveness of this treatment.