The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of a four-week dosing schedule for nivolumab for patients with advanced kidney cancer that has been previously treated. The dosing schedule will involve 480 mg nivolumab infused over 60 minutes. The CHMP also recommended approval of a two-week dosing option of 240 mg nivolumab infused over 30 minutes to replace weight-based dosing for all six approved indications in the EU. These recommendations will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).
This change in dosing schedule will bring big benefits for kidney cancer patients by halving the number of hospital visits for infusions (where clinically appropriate). This will make life very much easier for patients. KCSN are pleased to have been involved in lobbying for this change and say a big thank you to all our supporters and fundraisers who enable us to campaign for changes needed to improve the quality of life for patients.
We will keep you informed as to whether this change in dosing schedule will need to be appraised by the National Institute for Health and Care Excellence (NICE) before it becomes available on the NHS.