The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for an injectable form of nivolumab for the treatment of solid tumours, including advanced kidney cancer. The injectable form of nivolumab can be given alone, as maintenance therapy following completion of nivolumab plus ipilimumab combination treatment, or in combination with chemotherapy or cabozantinib.

The approval is based on the results from the phase 3 CheckMate-67T trial, which showed the injectable form of the drug allows large volumes of nivolumab, currently administered intravenously (IV) as an infusion, to be delivered as an injection under the skin (subcutaneous). The trial also showed that nivolumab given subcutaneously has similar effectiveness compared to the intravenous (IV) form of nivolumab.

This new option for giving nivolumab as a single injection administered in less than five minutes, could transform the treatment experience for both patients and doctors.

“The positive CHMP opinion is an important step forward in the evolution of immuno-oncology and in the potential of subcutaneous nivolumab to help transform the lives of people living with cancer,” said Bristol Myers Squibb, the manufacturers of nivolumab. “We look forward to bringing the same high-quality care that transformed cancer treatment with an administration method that has the potential to improve the patient experience and efficiency of healthcare systems in Europe.”

Subcutaneous administration may offer flexibility to receive treatment where it is best for patients and their healthcare team, and may reduce the steps needed for preparation and time for administration. With this approval, nivolumab is now the first and only subcutaneously administered immunotherapy, offering faster delivery for patients to receive this treatment option in three to five minutes compared to a 30-minute intravenous infusion of nivolumab.

This new form of nivolumab is yet to be approved for use in the UK by the regulators.

Read the Bristol Myers Squibb press release here